Drug · FAERS side-effect profile with label screen

Norethindrone side effects: what 309 FDA adverse event reports show

Norethindrone Acetate And Ethinyl Estradiol Tablets And Ferrous Fumarate Tablets · 13 reaction terms · 70 drug–reaction co-reports · data 2026-09-14

Drug class

Progestin

FDA label (Established Pharmacologic Class) · compare the class

Who reports

309 reports · 48% serious · 10 with death outcome · 100% female

openFDA FAERS counts, all years, deduplication not applied

Used for

1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.

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 8 strongest signals

Lab value / disease marker 1Not in label — unassessed 7

What the badges mean

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.

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. 5 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
Bursitis	10	56.1 30.5–103.3ROR 57.9 · χ² 487 / p 3e-108	50.9 EB05 29.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 80.1	no trial data cached
Helicobacter infection	7	46.5 22.3–96.7ROR 47.5 · χ² 268 / p 2e-60	41.5 EB05 21.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 59.6	no trial data cached
Folliculitis	6	39.3 17.8–86.8ROR 40.1 · χ² 187 / p 6e-43	34.9 EB05 16.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 56.1	no trial data cached
Foot deformity	6	36.6 16.6–80.8ROR 37.3 · χ² 174 / p 6e-40	32.7 EB05 15.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 51.6	no trial data cached
Body temperature decreased	5	34.1 14.3–81.3ROR 34.6 · χ² 129 / p 3e-30	29.4 EB05 11.8 · IC025 +1.5 3/3 methods agree	Lab value / disease marker	serious PRR 45.9	no trial data cached
Hand deformity	6	31.0 14.0–68.5ROR 31.6 · χ² 146 / p 8e-34	27.8 EB05 12.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 41.0	no trial data cached
Sleep disorder due to a general medical condition	6	25.1 11.4–55.5ROR 25.6 · χ² 116 / p 3e-27	22.2 EB05 9.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 30.2	no trial data cached
Dermatitis atopic	6	8.1 3.7–17.9ROR 8.3 · χ² 31 / p 1e-8	5.5 EB05 2.6 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	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
Bursitis	10	56.1 30.5–103.3ROR 57.9 · χ² 487 / p 3e-108	50.9 EB05 29.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 80.1	no trial data cached
Helicobacter infection	7	46.5 22.3–96.7ROR 47.5 · χ² 268 / p 2e-60	41.5 EB05 21.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 59.6	no trial data cached
Dermatitis atopic	6	8.1 3.7–17.9ROR 8.3 · χ² 31 / p 1e-8	5.5 EB05 2.6 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Sleep disorder due to a general medical condition	6	25.1 11.4–55.5ROR 25.6 · χ² 116 / p 3e-27	22.2 EB05 9.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 30.2	no trial data cached
Hand deformity	6	31.0 14.0–68.5ROR 31.6 · χ² 146 / p 8e-34	27.8 EB05 12.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 41.0	no trial data cached
Foot deformity	6	36.6 16.6–80.8ROR 37.3 · χ² 174 / p 6e-40	32.7 EB05 15.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 51.6	no trial data cached
Folliculitis	6	39.3 17.8–86.8ROR 40.1 · χ² 187 / p 6e-43	34.9 EB05 16.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 56.1	no trial data cached
Body temperature decreased	5	34.1 14.3–81.3ROR 34.6 · χ² 129 / p 3e-30	29.4 EB05 11.8 · IC025 +1.5 3/3 methods agree	Lab value / disease marker	serious PRR 45.9	no trial data cached
Needle issue	4	9.5 3.6–25.0ROR 9.6 · χ² 22 / p 1e-6	5.5 EB05 2.2 · IC025 +0.5 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Synovitis	4	15.0 5.7–39.7ROR 15.2 · χ² 39 / p 2e-10	9.3 EB05 3.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.1	no trial data cached
Pharyngitis streptococcal	4	25.0 9.4–66.2ROR 25.3 · χ² 70 / p 3e-17	18.9 EB05 4.9 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Menstruation irregular	3	7.6 2.5–23.6ROR 7.7 · χ² 11 / p 4e-4	4.2 EB05 1.6 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Labeled (related wording) related wording	serious n=1	no trial data cached
Pemphigus	3	16.3 5.3–50.3ROR 16.5 · χ² 29 / p 3e-8	8.7 EB05 2.3 · IC025 +0.3 3/3 methods agree	Not in label — unassessed	serious PRR 19.9	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: Medroxyprogesterone acetate ↔ Meningioma.

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 Norethindrone?

In FDA FAERS, the most frequently co-reported reaction terms for Norethindrone are bursitis, helicobacter infection, dermatitis atopic, sleep disorder due to a general medical condition, hand deformity, foot deformity. 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 Norethindrone have an FDA boxed warning?

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

Do FAERS signals prove that Norethindrone 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 0d2f8fea-3675-40d2-afd9-9fcb148dbd4b, effective 20260131; matched on openfda.generic_name.exact:"NORETHINDRONE")
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, 13 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.