Drug · FAERS side-effect profile with label screen
Norethindrone side effects: what 5,450 FDA adverse event reports show
Who reports
5,450 reports · 47% serious · 83 with death outcome · 99% 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 40 strongest signals
Labeled adverse reaction 7Labeled (related wording) 4Likely indication confounding 3Lab value / disease marker 1Not in label — unassessed 25
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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.
- 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. 316 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 |
|---|---|---|---|---|---|---|
| Pelvic pain | 181 | 37.9 32.8–43.7ROR 39.1 · χ² 6,400 / p <1e-300 | 37.4 EB05 33.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 28.0 · 79% consumer | no trial data cached |
| Menorrhagia (heavy periods) | 165 | 31.5 27.1–36.6ROR 32.4 · χ² 4,801 / p <1e-300 | 31.1 EB05 27.3 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.6 · 80% consumer | no trial data cached |
| Dysmenorrhoea | 89 | 25.8 21.0–31.7ROR 26.2 · χ² 2,085 / p <1e-300 | 25.5 EB05 21.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=35 · 84% consumer | no trial data cached |
| Metrorrhagia | 117 | 25.7 21.4–30.7ROR 26.2 · χ² 2,732 / p <1e-300 | 25.4 EB05 21.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=16 · 83% consumer | no trial data cached |
| Vaginal haemorrhage | 280 | 24.9 22.2–28.0ROR 26.2 · χ² 6,381 / p <1e-300 | 24.7 EB05 22.4 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.5 · 74% consumer | no trial data cached |
| Ovarian cyst | 55 | 20.7 15.9–27.0ROR 20.9 · χ² 1,007 / p 2e-221 | 20.5 EB05 16.3 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.9 | no trial data cached |
| Hot flush (hot flashes) | 370 | 18.6 16.8–20.5ROR 19.8 · χ² 6,130 / p <1e-300 | 18.5 EB05 17.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 · 85% consumer | no trial data cached |
| Mood swings | 154 | 18.3 15.6–21.4ROR 18.8 · χ² 2,489 / p <1e-300 | 18.2 EB05 15.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · 85% consumer | no trial data cached |
| Hereditary angioedema | 38 | 13.7 10.0–18.8ROR 13.8 · χ² 433 / p 2e-96 | 13.4 EB05 10.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 · 74% consumer | no trial data cached |
| Menstruation irregular | 89 | 12.7 10.3–15.6ROR 12.9 · χ² 944 / p 2e-207 | 12.5 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=26 · 85% consumer | no trial data cached |
| Amenorrhoea (missed periods) | 51 | 11.5 8.8–15.2ROR 11.6 · χ² 480 / p 1e-106 | 11.2 EB05 8.7 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.5 · 81% consumer | no trial data cached |
| Night sweats | 95 | 11.1 9.1–13.6ROR 11.3 · χ² 866 / p 1e-190 | 11.0 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 86% consumer | no trial data cached |
| Vaginal discharge | 24 | 9.0 6.0–13.5ROR 9.1 · χ² 163 / p 1e-37 | 8.1 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=7 · 74% consumer | no trial data cached |
| Migraine | 209 | 8.3 7.3–9.5ROR 8.6 · χ² 1,341 / p 6e-294 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 72% consumer | no trial data cached |
| Mood altered | 56 | 7.8 6.0–10.1ROR 7.8 · χ² 324 / p 1e-72 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 75% consumer | no trial data cached |
| Blood iron decreased | 23 | 7.4 4.9–11.1ROR 7.4 · χ² 120 / p 3e-28 | 6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 9.8 | no trial data cached |
| Menstruation delayed | 18 | 6.5 4.1–10.4ROR 6.6 · χ² 79 / p 3e-19 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Crying | 62 | 6.4 5.0–8.2ROR 6.5 · χ² 278 / p 1e-62 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 76% consumer | no trial data cached |
| Breast cancer metastatic | 18 | 6.3 4.0–10.0ROR 6.3 · χ² 75 / p 2e-18 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Transfusion | 17 | 6.1 3.8–9.8ROR 6.1 · χ² 67 / p 1e-16 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Libido decreased (lower sex drive) | 20 | 6.1 3.9–9.4ROR 6.1 · χ² 80 / p 2e-19 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Insurance issue | 23 | 5.8 3.9–8.8ROR 5.9 · χ² 87 / p 4e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · 87% consumer | no trial data cached |
| Breast pain | 16 | 5.7 3.5–9.2ROR 5.7 · χ² 57 / p 2e-14 | 4.9 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=6 | no trial data cached |
| Infusion site pain | 19 | 5.6 3.6–8.8ROR 5.6 · χ² 67 / p 1e-16 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Rash maculo-papular | 32 | 5.4 3.9–7.7ROR 5.5 · χ² 112 / p 2e-26 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Impaired gastric emptying | 18 | 5.3 3.4–8.4ROR 5.3 · χ² 59 / p 8e-15 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Abdominal pain lower | 35 | 5.2 3.7–7.2ROR 5.2 · χ² 115 / p 4e-27 | 4.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 | no trial data cached |
| Coeliac disease | 13 | 5.0 2.9–8.6ROR 5.0 · χ² 38 / p 4e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Dermatitis contact | 15 | 5.0 3.0–8.3ROR 5.0 · χ² 44 / p 2e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Middle insomnia | 24 | 4.9 3.3–7.3ROR 4.9 · χ² 70 / p 3e-17 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Emotional disorder | 40 | 4.9 3.6–6.6ROR 4.9 · χ² 119 / p 5e-28 | 4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 83% consumer | no trial data cached |
| Cyst | 15 | 4.6 2.7–7.5ROR 4.6 · χ² 38 / p 3e-10 | 4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 | no trial data cached |
| Abdominal pain | 273 | 4.4 3.9–5.0ROR 4.6 · χ² 729 / p 9e-161 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 70% consumer | no trial data cached |
| Abdominal distension (bloating) | 120 | 4.4 3.6–5.2ROR 4.4 · χ² 308 / p 3e-69 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Melaena (black stool) | 25 | 4.3 2.9–6.3ROR 4.3 · χ² 59 / p 6e-15 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Embedded device | 11 | 4.2 2.3–7.6ROR 4.2 · χ² 24 / p 5e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Pregnancy | 22 | 4.1 2.7–6.2ROR 4.1 · χ² 49 / p 2e-12 | 3.8 EB05 2.7 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.8 | no trial data cached |
| Seasonal allergy | 15 | 4.0 2.4–6.6ROR 4.0 · χ² 31 / p 1e-8 | 3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | no trial data cached |
| Panic attack | 38 | 3.9 2.9–5.4ROR 3.9 · χ² 80 / p 2e-19 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 76% consumer | no trial data cached |
| Affect lability | 10 | 3.9 2.1–7.2ROR 3.9 · χ² 19 / p 7e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | 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 | 467 | 2.2 2.0–2.4ROR 2.3 · χ² 328 / p 1e-73 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Headache | 440 | 2.6 2.4–2.9ROR 2.8 · χ² 464 / p 4e-103 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 · 72% consumer | no trial data cached |
| Hot flush (hot flashes) | 370 | 18.6 16.8–20.5ROR 19.8 · χ² 6,130 / p <1e-300 | 18.5 EB05 17.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 · 85% consumer | no trial data cached |
| Pain | 315 | 1.9 1.7–2.1ROR 2.0 · χ² 144 / p 1e-33 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Vaginal haemorrhage | 280 | 24.9 22.2–28.0ROR 26.2 · χ² 6,381 / p <1e-300 | 24.7 EB05 22.4 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.5 · 74% consumer | no trial data cached |
| Abdominal pain | 273 | 4.4 3.9–5.0ROR 4.6 · χ² 729 / p 9e-161 | 4.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 70% consumer | no trial data cached |
| Arthralgia (joint pain) | 233 | 2.1 1.9–2.4ROR 2.2 · χ² 139 / p 2e-32 | 2.1 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Anxiety | 214 | 2.8 2.5–3.2ROR 2.9 · χ² 254 / p 1e-57 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Migraine | 209 | 8.3 7.3–9.5ROR 8.6 · χ² 1,341 / p 6e-294 | 8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 72% consumer | no trial data cached |
| Depression | 201 | 3.3 2.9–3.8ROR 3.4 · χ² 326 / p 3e-73 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 · 70% consumer | no trial data cached |
| Weight increased (weight gain) | 181 | 3.1 2.7–3.5ROR 3.1 · χ² 252 / p 5e-57 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 · 72% consumer | no trial data cached |
| Pelvic pain | 181 | 37.9 32.8–43.7ROR 39.1 · χ² 6,400 / p <1e-300 | 37.4 EB05 33.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 28.0 · 79% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 179 | 2.5 2.2–2.9ROR 2.6 · χ² 166 / p 3e-38 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 · 76% consumer | no trial data cached |
| Menorrhagia (heavy periods) | 165 | 31.5 27.1–36.6ROR 32.4 · χ² 4,801 / p <1e-300 | 31.1 EB05 27.3 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.6 · 80% consumer | no trial data cached |
| Product dose omission issue | 164 | 2.2 1.9–2.5ROR 2.2 · χ² 104 / p 1e-24 | 2.2 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 4.7 · 70% consumer | 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.
- Pelvic pain — n=181, PRR 37.9
- Dysmenorrhoea — n=89, PRR 25.8
- Metrorrhagia — n=117, PRR 25.7
- Hot flush — n=370, PRR 18.6
- Mood swings — n=154, PRR 18.3
- Hereditary angioedema — n=38, PRR 13.7
- Night sweats — n=95, PRR 11.1
- Migraine — n=209, PRR 8.3
- Mood altered — n=56, PRR 7.8
- Crying — n=62, PRR 6.4
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 nausea, headache, hot flush, pain, vaginal haemorrhage, abdominal pain. 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, fieldpatient.drug.openfda.generic_name.exact, 356 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.