Drug · FAERS side-effect profile with label screen

Desogestrel side effects: what 283 FDA adverse event reports show

Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol · 9 reaction terms · 76 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol (Desogestrel And Ethinyl Estradiol And Ethinyl Estradiol)

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

Who reports

283 reports · 28% serious · 1 with death outcome · 97% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Desogestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.

FDA label, Indications and Usage

What it is

DESCRIPTION Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP provide an oral contraceptive regimen of 21 white to off-white round tablets each containing 0.15 .

FDA label, Description section

Boxed warning

CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.

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 6 strongest signals

Labeled (related wording) 1Reporting / coding artifact 2Not in label — unassessed 3

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.
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. 3 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
Metrorrhagia	6	25.7 11.6–56.8ROR 26.2 · χ² 119 / p 5e-28	22.8 EB05 9.3 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product substitution issue	14	18.0 10.8–30.0ROR 18.9 · χ² 209 / p 1e-47	17.3 EB05 10.4 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 22.3	no trial data cached
Menstruation irregular	6	16.8 7.6–37.0ROR 17.1 · χ² 74 / p 4e-18	13.3 EB05 4.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Vaginal haemorrhage	8	13.9 7.0–27.6ROR 14.3 · χ² 84 / p 3e-20	11.4 EB05 5.1 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.0	no trial data cached
Dermatitis atopic	7	10.4 5.0–21.6ROR 10.6 · χ² 50 / p 6e-13	7.5 EB05 3.5 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Drug dose omission	23	10.2 6.9–15.0ROR 11.0 · χ² 182 / p 7e-42	9.3 EB05 6.2 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	100% consumer	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
Drug dose omission	23	10.2 6.9–15.0ROR 11.0 · χ² 182 / p 7e-42	9.3 EB05 6.2 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Product substitution issue	14	18.0 10.8–30.0ROR 18.9 · χ² 209 / p 1e-47	17.3 EB05 10.4 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 22.3	no trial data cached
Vaginal haemorrhage	8	13.9 7.0–27.6ROR 14.3 · χ² 84 / p 3e-20	11.4 EB05 5.1 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.0	no trial data cached
Dermatitis atopic	7	10.4 5.0–21.6ROR 10.6 · χ² 50 / p 6e-13	7.5 EB05 3.5 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Menstruation irregular	6	16.8 7.6–37.0ROR 17.1 · χ² 74 / p 4e-18	13.3 EB05 4.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Metrorrhagia	6	25.7 11.6–56.8ROR 26.2 · χ² 119 / p 5e-28	22.8 EB05 9.3 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Menorrhagia (heavy periods)	4	14.9 5.6–39.4ROR 15.1 · χ² 39 / p 2e-10	9.2 EB05 2.9 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Menstruation delayed	4	28.5 10.8–75.5ROR 28.9 · χ² 81 / p 1e-19	22.3 EB05 5.9 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Vaginal discharge	4	29.5 11.2–78.1ROR 29.9 · χ² 84 / p 3e-20	23.2 EB05 6.2 · IC025 +1.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	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: 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 Desogestrel?

In FDA FAERS, the most frequently co-reported reaction terms for Desogestrel are vaginal haemorrhage, dermatitis atopic, menstruation irregular, metrorrhagia, menorrhagia, menstruation delayed. 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 Desogestrel have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.

Do FAERS signals prove that Desogestrel 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 142c4b90-c9ab-45ce-9172-f1ea7d366686, effective 20230801; matched on openfda.generic_name.exact:"DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL 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, field patient.drug.openfda.generic_name.exact, 9 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.