Norethindrone Acetate

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Norethindrone Acetate
Generic name
NORETHINDRONE ACETATE
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
d0a94321-eb60-4aa6-a429-f0156f9f8e01
SPL ID
61f08f82-c9ec-45cf-ab8b-18afabde75e2
Version
10
Effective date
2026-01-29
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:38:59
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS 1. Cardiovascular disorders Patients with risk factors for arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. 2. Visual abnormalities Discontinue medication pending examination if there is a sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia, or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be discontinued.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS See WARNINGS and PRECAUTIONS . The following adverse reactions have been observed in women taking progestins: • Breakthrough bleeding • Spotting • Change in menstrual flow • Amenorrhea • Edema • Changes in weight (decreases, increases) • Changes in the cervical squamo-columnar junction and cervical secretions • Cholestatic jaundice • Rash (allergic) with and without pruritus • Melasma or chloasma • Clinical depression • Acne • Breast enlargement/tenderness • Headache/migraine • Urticaria • Abnormalities of liver tests (i.e., AST, ALT, Bilirubin) • Decreased HDL cholesterol and increased LDL/HDL ratio • Mood swings • Nausea • Insomnia • Anaphylactic/anaphylactoid reactions • Thrombotic and thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, cerebral thrombosis and embolism) • Optic neuritis (which may lead to partial or complete loss of vision)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.