Drug · FAERS side-effect profile with label screen
Estriol0.2% side effects: what 1,735 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,735 reports · 88% serious · 43 with death outcome · 89% female
openFDA FAERS counts, all years, deduplication not applied
Used for
1. Clean the affected area of the skin. 2. Apply 1-2ml in the area where it is needed. 3. Spread it evenly over the remaining part of the area. 4. Continue to use every day.
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 2Lab value / disease marker 2No 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.
- 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.
- 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. 78 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 |
|---|---|---|---|---|---|---|
| Subarachnoid haemorrhage | 371 | 455.9 415.6–500.0ROR 579.7 · χ² 161,831 / p <1e-300 | 429.4 EB05 393.9 · IC025 +7.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 288.2 · ♀ 52% (drug 89%) | no trial data cached |
| Vasculitis | 367 | 393.1 358.3–431.3ROR 498.4 · χ² 138,670 / p <1e-300 | 373.2 EB05 342.2 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 268.6 · ♀ 53% (drug 89%) | no trial data cached |
| Anosmia (loss of smell) | 370 | 316.6 288.9–347.1ROR 402.3 · χ² 113,182 / p <1e-300 | 303.6 EB05 278.5 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=370 · ♀ 52% (drug 89%) | no trial data cached |
| Pericarditis | 371 | 275.4 251.3–301.8ROR 350.1 · χ² 98,947 / p <1e-300 | 265.5 EB05 243.6 · IC025 +7.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 177.9 · ♀ 52% (drug 89%) | no trial data cached |
| Ventricular tachycardia | 365 | 272.4 248.3–298.8ROR 344.7 · χ² 96,299 / p <1e-300 | 262.7 EB05 240.8 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 176.2 · ♀ 53% (drug 89%) | no trial data cached |
| Muscle twitching | 377 | 200.5 183.2–219.5ROR 256.0 · χ² 73,493 / p <1e-300 | 195.3 EB05 179.3 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 201.6 · ♀ 55% (drug 89%) | no trial data cached |
| Diplopia (double vision) | 365 | 172.4 157.2–189.0ROR 218.0 · χ² 61,203 / p <1e-300 | 168.4 EB05 154.4 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 152.5 · ♀ 53% (drug 89%) | no trial data cached |
| Pain of skin | 366 | 166.2 151.6–182.1ROR 210.4 · χ² 59,177 / p <1e-300 | 162.5 EB05 149.0 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 410.8 · ♀ 53% (drug 89%) | no trial data cached |
| Rash papular | 266 | 144.9 129.7–162.0ROR 171.0 · χ² 37,462 / p <1e-300 | 141.8 EB05 128.0 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 235.9 · ♀ 50% (drug 89%) | no trial data cached |
| Lip swelling | 391 | 144.0 131.9–157.2ROR 185.6 · χ² 54,803 / p <1e-300 | 141.3 EB05 129.9 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 149.0 · ♀ 55% (drug 89%) | no trial data cached |
| Eye pruritus | 362 | 134.3 122.4–147.2ROR 169.4 · χ² 47,289 / p <1e-300 | 131.9 EB05 120.8 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 323.3 · ♀ 53% (drug 89%) | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 367 | 132.4 120.8–145.1ROR 167.7 · χ² 47,282 / p <1e-300 | 130.1 EB05 119.3 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.3 · ♀ 53% (drug 89%) | no trial data cached |
| Blindness | 366 | 109.7 100.1–120.2ROR 138.8 · χ² 39,029 / p <1e-300 | 108.1 EB05 99.1 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.0 · ♀ 52% (drug 89%) | no trial data cached |
| Angioedema (deep swelling of face/throat) | 386 | 106.7 97.6–116.5ROR 136.9 · χ² 40,032 / p <1e-300 | 105.2 EB05 96.7 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.3 · ♀ 54% (drug 89%) | no trial data cached |
| Cognitive disorder | 384 | 100.7 92.1–110.0ROR 129.0 · χ² 37,554 / p <1e-300 | 99.3 EB05 91.3 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 91.7 · ♀ 55% (drug 89%) | no trial data cached |
| Tinnitus (ringing in the ears) | 372 | 98.6 90.0–107.9ROR 125.2 · χ² 35,609 / p <1e-300 | 97.3 EB05 89.3 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.0 · ♀ 54% (drug 89%) | no trial data cached |
| Disturbance in attention | 379 | 85.3 78.0–93.3ROR 108.9 · χ² 31,364 / p <1e-300 | 84.4 EB05 77.5 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.6 · ♀ 53% (drug 89%) | no trial data cached |
| Amnesia (memory loss) | 371 | 69.1 63.1–75.6ROR 87.6 · χ² 24,752 / p <1e-300 | 68.4 EB05 62.8 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.9 · ♀ 52% (drug 89%) | no trial data cached |
| Hallucination (hallucinations) | 375 | 60.8 55.6–66.5ROR 77.3 · χ² 21,963 / p <1e-300 | 60.3 EB05 55.4 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.2 · ♀ 53% (drug 89%) | no trial data cached |
| Tachycardia (fast heart rate) | 371 | 50.7 46.3–55.5ROR 64.2 · χ² 18,027 / p <1e-300 | 50.4 EB05 46.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.7 · ♀ 54% (drug 89%) | no trial data cached |
| Migraine | 393 | 50.3 46.1–54.9ROR 64.7 · χ² 18,946 / p <1e-300 | 50.0 EB05 46.0 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 63.7 · ♀ 55% (drug 89%) | no trial data cached |
| Intentional product misuse | 349 | 48.8 44.4–53.6ROR 60.8 · χ² 16,288 / p <1e-300 | 48.5 EB05 44.3 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 71.9 · ♀ 53% (drug 89%) | no trial data cached |
| Heart rate increased | 375 | 46.0 42.0–50.3ROR 58.4 · χ² 16,465 / p <1e-300 | 45.7 EB05 41.9 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious PRR 44.7 · ♀ 55% (drug 89%) | no trial data cached |
| Muscular weakness | 394 | 42.1 38.6–45.9ROR 54.1 · χ² 15,786 / p <1e-300 | 41.8 EB05 38.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.8 · ♀ 55% (drug 89%) | no trial data cached |
| Palpitations (pounding heartbeat) | 399 | 41.4 38.0–45.1ROR 53.4 · χ² 15,715 / p <1e-300 | 41.2 EB05 37.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.9 · ♀ 57% (drug 89%) | no trial data cached |
| Intentional product use issue | 285 | 39.3 35.3–43.7ROR 46.8 · χ² 10,613 / p <1e-300 | 39.1 EB05 35.4 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 37.5 · ♀ 51% (drug 89%) | no trial data cached |
| Visual impairment | 391 | 38.6 35.3–42.1ROR 49.5 · χ² 14,303 / p <1e-300 | 38.4 EB05 35.3 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.1 · ♀ 55% (drug 89%) | no trial data cached |
| Hyperhidrosis (excessive sweating) | 379 | 35.6 32.6–39.0ROR 45.3 · χ² 12,768 / p <1e-300 | 35.5 EB05 32.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.1 · ♀ 54% (drug 89%) | no trial data cached |
| Dry skin | 378 | 34.8 31.9–38.1ROR 44.3 · χ² 12,435 / p <1e-300 | 34.7 EB05 31.9 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 98.3 · ♀ 54% (drug 89%) | no trial data cached |
| Memory impairment | 389 | 34.3 31.4–37.4ROR 43.9 · χ² 12,587 / p <1e-300 | 34.1 EB05 31.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.6 · ♀ 56% (drug 89%) | no trial data cached |
| Dehydration | 371 | 33.7 30.8–36.9ROR 42.6 · χ² 11,790 / p <1e-300 | 33.6 EB05 30.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.5 · ♀ 53% (drug 89%) | no trial data cached |
| Peripheral swelling | 381 | 30.1 27.5–32.9ROR 38.3 · χ² 10,741 / p <1e-300 | 30.0 EB05 27.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.7 · ♀ 55% (drug 89%) | no trial data cached |
| Abdominal discomfort | 383 | 27.8 25.4–30.3ROR 35.4 · χ² 9,913 / p <1e-300 | 27.7 EB05 25.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.5 · ♀ 54% (drug 89%) | no trial data cached |
| Covid-19 | 388 | 26.6 24.3–29.0ROR 33.9 · χ² 9,584 / p <1e-300 | 26.5 EB05 24.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.2 · ♀ 54% (drug 89%) | no trial data cached |
| Chest pain | 390 | 25.5 23.3–27.8ROR 32.6 · χ² 9,204 / p <1e-300 | 25.4 EB05 23.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.8 · ♀ 54% (drug 89%) | no trial data cached |
| Myocardial infarction (heart attack) | 368 | 25.4 23.2–27.8ROR 31.9 · χ² 8,641 / p <1e-300 | 25.3 EB05 23.2 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.7 · ♀ 53% (drug 89%) | no trial data cached |
| Alopecia (hair loss) | 396 | 24.4 22.4–26.6ROR 31.3 · χ² 8,923 / p <1e-300 | 24.3 EB05 22.4 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.7 · ♀ 57% (drug 89%) | no trial data cached |
| Blood glucose increased | 367 | 23.5 21.5–25.7ROR 29.5 · χ² 7,942 / p <1e-300 | 23.4 EB05 21.5 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 38.1 · ♀ 53% (drug 89%) | no trial data cached |
| Abdominal pain upper | 361 | 21.3 19.4–23.3ROR 26.6 · χ² 7,016 / p <1e-300 | 21.2 EB05 19.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.6 · ♀ 59% (drug 89%) | no trial data cached |
| Conjunctivitis | 31 | 20.4 14.4–29.0ROR 20.8 · χ² 553 / p 1e-122 | 20.2 EB05 14.8 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.8 | 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 | 516 | 7.9 7.4–8.5ROR 10.8 · χ² 3,229 / p <1e-300 | 7.9 EB05 7.3 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 · ♀ 68% (drug 89%) | no trial data cached |
| Fatigue (tiredness) | 474 | 7.4 6.8–8.0ROR 9.8 · χ² 2,708 / p <1e-300 | 7.3 EB05 6.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.9 · ♀ 63% (drug 89%) | no trial data cached |
| Headache | 469 | 9.1 8.4–9.8ROR 12.1 · χ² 3,458 / p <1e-300 | 9.0 EB05 8.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 · ♀ 64% (drug 89%) | no trial data cached |
| Diarrhoea (diarrhea) | 467 | 8.8 8.1–9.5ROR 11.7 · χ² 3,314 / p <1e-300 | 8.7 EB05 8.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 · ♀ 63% (drug 89%) | no trial data cached |
| Dyspnoea (shortness of breath) | 448 | 9.6 8.9–10.4ROR 12.6 · χ² 3,529 / p <1e-300 | 9.5 EB05 8.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 · ♀ 61% (drug 89%) | no trial data cached |
| Dizziness | 435 | 10.6 9.7–11.5ROR 13.8 · χ² 3,850 / p <1e-300 | 10.5 EB05 9.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 · ♀ 61% (drug 89%) | no trial data cached |
| Vomiting | 434 | 11.2 10.3–12.2ROR 14.6 · χ² 4,111 / p <1e-300 | 11.2 EB05 10.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 · ♀ 61% (drug 89%) | no trial data cached |
| Pain | 427 | 8.4 7.7–9.1ROR 10.8 · χ² 2,857 / p <1e-300 | 8.3 EB05 7.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 · ♀ 58% (drug 89%) | no trial data cached |
| Malaise (feeling unwell) | 420 | 11.6 10.6–12.6ROR 14.9 · χ² 4,126 / p <1e-300 | 11.5 EB05 10.6 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 · ♀ 58% (drug 89%) | no trial data cached |
| Arthralgia (joint pain) | 413 | 12.1 11.1–13.1ROR 15.5 · χ² 4,260 / p <1e-300 | 12.0 EB05 11.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.0 · ♀ 57% (drug 89%) | no trial data cached |
| Pyrexia (fever) | 399 | 14.0 12.8–15.2ROR 17.8 · χ² 4,859 / p <1e-300 | 13.9 EB05 12.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.5 · ♀ 57% (drug 89%) | no trial data cached |
| Feeling abnormal | 399 | 20.1 18.4–21.9ROR 25.8 · χ² 7,290 / p <1e-300 | 20.0 EB05 18.4 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.2 · ♀ 55% (drug 89%) | no trial data cached |
| Palpitations (pounding heartbeat) | 399 | 41.4 38.0–45.1ROR 53.4 · χ² 15,715 / p <1e-300 | 41.2 EB05 37.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.9 · ♀ 57% (drug 89%) | no trial data cached |
| Insomnia (trouble sleeping) | 397 | 18.0 16.5–19.7ROR 23.1 · χ² 6,438 / p <1e-300 | 18.0 EB05 16.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.8 · ♀ 57% (drug 89%) | no trial data cached |
| Alopecia (hair loss) | 396 | 24.4 22.4–26.6ROR 31.3 · χ² 8,923 / p <1e-300 | 24.3 EB05 22.4 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.7 · ♀ 57% (drug 89%) | 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 Estriol0.2%?
In FDA FAERS, the most frequently co-reported reaction terms for Estriol0.2% are nausea, fatigue, headache, diarrhoea, dyspnoea, dizziness. 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 Estriol0.2% have an FDA boxed warning?
No. The FDA label retrieved for Estriol0.2% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Estriol0.2% 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 42e4cc84-7c00-6937-e063-6294a90a0c09, effective 20251105; matched on
openfda.generic_name.exact:"ESTRIOL0.2%") - 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, 118 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.