Drug · FAERS side-effect profile with label screen

Norgestrel and Ethinyl Estradiol side effects: what 904 FDA adverse event reports show

Norgestrel And Ethinyl Estradiol · 24 reaction terms · 326 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Norgestrel (Daily Oral Contraceptive)

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

Who reports

904 reports · 41% serious · 12 with death outcome · 99% female

openFDA FAERS counts, all years, deduplication not applied

Used for

To prevent pregnancy

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 16 strongest signals

Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 2Not in label — unassessed 11

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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. 8 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
Unintended pregnancy	45	100.2 75.3–133.3ROR 105.4 · χ² 4,304 / p <1e-300	95.8 EB05 74.5 · IC025 +5.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 53.2 · 88% consumer	no trial data cached
Metrorrhagia	43	57.8 43.2–77.4ROR 60.6 · χ² 2,340 / p <1e-300	56.3 EB05 43.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=5 · 81% consumer	no trial data cached
Menorrhagia (heavy periods)	22	25.6 17.0–38.8ROR 26.3 · χ² 496 / p 3e-110	25.1 EB05 17.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 36.9	no trial data cached
Dysmenorrhoea	12	21.3 12.1–37.4ROR 21.6 · χ² 212 / p 2e-48	20.4 EB05 12.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Vaginal haemorrhage	27	14.7 10.1–21.3ROR 15.1 · χ² 332 / p 2e-74	14.3 EB05 10.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 24.3 · 88% consumer	no trial data cached
Menstruation irregular	13	11.4 6.6–19.5ROR 11.5 · χ² 113 / p 1e-26	9.8 EB05 5.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Product quality issue	66	11.4 9.0–14.3ROR 12.2 · χ² 617 / p 2e-136	11.1 EB05 9.0 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 21.3 · 82% consumer	no trial data cached
Impaired quality of life	7	11.3 5.4–23.6ROR 11.4 · χ² 56 / p 4e-14	8.3 EB05 3.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Menstruation delayed	5	11.2 4.7–26.8ROR 11.2 · χ² 37 / p 7e-10	7.2 EB05 2.9 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Amenorrhoea (missed periods)	7	9.7 4.7–20.4ROR 9.8 · χ² 46 / p 5e-12	7.0 EB05 3.3 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.9	no trial data cached
Product physical issue	6	7.0 3.1–15.5ROR 7.0 · χ² 25 / p 3e-7	4.9 EB05 2.4 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Emotional disorder	9	6.7 3.5–12.9ROR 6.8 · χ² 38 / p 3e-10	5.2 EB05 2.9 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Abortion spontaneous	11	6.3 3.5–11.4ROR 6.4 · χ² 44 / p 1e-11	5.1 EB05 3.1 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.2	no trial data cached
Pregnancy	5	5.7 2.4–13.7ROR 5.8 · χ² 15 / p 5e-5	4.0 EB05 1.9 · IC025 +0.4	Likely indication confounding term in indications; also in warnings	serious PRR 11.8	no trial data cached
Dermatitis atopic	10	4.6 2.5–8.6ROR 4.7 · χ² 25 / p 3e-7	3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Multiple sclerosis relapse	11	3.7 2.1–6.6ROR 3.7 · χ² 19 / p 6e-6	3.3 EB05 2.0 · IC025 +0.7	Not in label — unassessed	serious PRR 3.3	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
Product quality issue	66	11.4 9.0–14.3ROR 12.2 · χ² 617 / p 2e-136	11.1 EB05 9.0 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 21.3 · 82% consumer	no trial data cached
Unintended pregnancy	45	100.2 75.3–133.3ROR 105.4 · χ² 4,304 / p <1e-300	95.8 EB05 74.5 · IC025 +5.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 53.2 · 88% consumer	no trial data cached
Metrorrhagia	43	57.8 43.2–77.4ROR 60.6 · χ² 2,340 / p <1e-300	56.3 EB05 43.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=5 · 81% consumer	no trial data cached
Vaginal haemorrhage	27	14.7 10.1–21.3ROR 15.1 · χ² 332 / p 2e-74	14.3 EB05 10.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 24.3 · 88% consumer	no trial data cached
Menorrhagia (heavy periods)	22	25.6 17.0–38.8ROR 26.3 · χ² 496 / p 3e-110	25.1 EB05 17.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 36.9	no trial data cached
Menstruation irregular	13	11.4 6.6–19.5ROR 11.5 · χ² 113 / p 1e-26	9.8 EB05 5.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Dysmenorrhoea	12	21.3 12.1–37.4ROR 21.6 · χ² 212 / p 2e-48	20.4 EB05 12.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Multiple sclerosis relapse	11	3.7 2.1–6.6ROR 3.7 · χ² 19 / p 6e-6	3.3 EB05 2.0 · IC025 +0.7	Not in label — unassessed	serious PRR 3.3	no trial data cached
Abortion spontaneous	11	6.3 3.5–11.4ROR 6.4 · χ² 44 / p 1e-11	5.1 EB05 3.1 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.2	no trial data cached
Dermatitis atopic	10	4.6 2.5–8.6ROR 4.7 · χ² 25 / p 3e-7	3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Emotional disorder	9	6.7 3.5–12.9ROR 6.8 · χ² 38 / p 3e-10	5.2 EB05 2.9 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Amenorrhoea (missed periods)	7	9.7 4.7–20.4ROR 9.8 · χ² 46 / p 5e-12	7.0 EB05 3.3 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.9	no trial data cached
Impaired quality of life	7	11.3 5.4–23.6ROR 11.4 · χ² 56 / p 4e-14	8.3 EB05 3.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Product physical issue	6	7.0 3.1–15.5ROR 7.0 · χ² 25 / p 3e-7	4.9 EB05 2.4 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Pregnancy	5	5.7 2.4–13.7ROR 5.8 · χ² 15 / p 5e-5	4.0 EB05 1.9 · IC025 +0.4	Likely indication confounding term in indications; also in warnings	serious PRR 11.8	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.

Metrorrhagia — n=43, PRR 57.8
Menorrhagia — n=22, PRR 25.6
Vaginal haemorrhage — n=27, PRR 14.7

✓ 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 Norgestrel and Ethinyl Estradiol?

In FDA FAERS, the most frequently co-reported reaction terms for Norgestrel and Ethinyl Estradiol are unintended pregnancy, metrorrhagia, vaginal haemorrhage, menorrhagia, menstruation irregular, dysmenorrhoea. 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 Norgestrel and Ethinyl Estradiol have an FDA boxed warning?

No. The FDA label retrieved for Norgestrel and Ethinyl Estradiol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Norgestrel and Ethinyl 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 20477912-c1d6-4190-8f6e-00fb122134a1, effective 20260806; matched on openfda.generic_name.exact:"NORGESTREL")
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, 24 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.