Norethindrone

Mechanism-of-action class: Progestational Hormone Receptor Agonists.

• 1. Indications Progestin - only oral contraceptives are indicated for the prevention of pregnancy.ICD-10: Z30.9

• Progestin - only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy Known or suspected carcinoma of the breast Undiagnosed abnormal genital bleeding Hypersensitivity to any component of this product Benign or malignant liver tumors Acute liver diseasecontraindicated

To achieve maximum contraceptive effectiveness, Incassia tablets must be taken exactly as directed. One tablet is taken every day, at the same time. Administration is continuous, with no interruption between pill packs. See PATIENT LABELING for detailed instructions.

Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke. Incassia does not contain estrogen and, therefore, this insert does not discuss the serious health risks that have been associated with the estrogen component of combined oral contraceptives. The health care provider is referred to the prescribing information of combined oral contraceptives for a discussion of those risks, including, but not limited to, an increased risk of serious cardiovascular disease in women who smoke, carcinoma of the breast and reproductive organs, hepatic neoplasia, and changes in carbohydrate and lipid metabolism. The relationship between progestin-only oral contraceptives and these risks have not been established and there are no studies definitely linking progestin - only pill (POP) use to an increased risk of heart attack or stroke. The physician should remain alert to the earliest manifestation of symptoms of any serious disease and discontinue oral contraceptive therapy when appropriate. 1 . Ectopic Pregnancy The incidence of ectopic pregnancies for progestin - only oral contraceptive users is 5 per 1000 woman-years. Up to 10% of pregnancies reported in clinical studies of progestin-only oral contraceptive users are extrauterine. Although symptoms of ectopic pregnancy should be watched for, a history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method.

Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding are common, while long duration of bleeding episodes and amenorrhea are less likely. Headache, breast tenderness, nausea, and dizziness are increased among progestin-only oral contraceptive users in some studies. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.

There have been no reports of serious ill effects from overdosage, including ingestion by children.

• Jan 2, 1973NDANDA017060Teva Branded Pharm
• Feb 28, 1992ANDAANDA072693Barr
• Aug 7, 1998NDANDA020870Noven Pharms Inc
• Nov 18, 1998NDANDA020907Amneal
• Oct 21, 2010NDANDA022501Apil
• Apr 19, 2013NDANDA204426Apil
• May 26, 2021NDANDA214846Sumitomo Pharma Am
• Jul 22, 2024NDANDA218718Millicent Pr

1. 1Nausea1,3037.3%
2. 2Headache1,1786.6%
3. 3Off Label Use9955.5%
4. 4Drug Ineffective9605.3%
5. 5Fatigue9155.1%
6. 6Pain7814.3%
7. 7Anxiety6693.7%
8. 8Dizziness6463.6%
9. 9Diarrhoea5853.3%
10. 10Depression5813.2%
11. 11Vomiting5693.2%
12. 12Hot Flush5603.1%
13. 13Therapy Interrupted5323.0%
14. 14Abdominal Pain5272.9%
15. 15Vaginal Haemorrhage5012.8%

Recent PubMed references pinned to Norethindrone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Comparative adverse event reporting patterns of desogestrel versus norethisterone in third-generation combined oral contraceptives: A disproportionality analysis of the FAERS satabase.
  Medicine · 2026 · Li J, Qin L, Fu Y, et al.
  PMID 42175417DOI 10.1097/MD.0000000000048669
• Relugolix combination therapy in symptomatic adenomyosis and uterine fibroids: a case series.
  Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology · 2026 · Saponara S, D'Alterio MN, Di Michele S, et al.
  PMID 41999195DOI 10.1080/09513590.2026.2659439
• Injectable contraceptives differentially affect the hypothalamic-pituitary-gonadal axis and amenorrhea incidence†.
  Biology of reproduction · 2026 · Bick AJ, Avenant C, Capitaine CK, et al.
  PMID 41489365DOI 10.1093/biolre/ioaf292
• Non-additive effects of norethisterone and levonorgestrel mixtures on lipid metabolism at environmentally relevant concentrations.
  Aquatic toxicology (Amsterdam, Netherlands) · 2026 · Zhang Z, Zhou K, Chen Y, et al.
  PMID 41443170DOI 10.1016/j.aquatox.2025.107686
• Risks of pelvic inflammatory disease and bacterial vaginosis in adenomyosis patients using levonorgestrel intrauterine device or oral norethindrone.
  Frontiers in endocrinology · 2025 · Niu SY, Yi YC, Shih YH, et al.
  PMID 41404506DOI 10.3389/fendo.2025.1703310
• Management of uterine leiomyoma and adenomyosis: role of hysteroscopy in diagnosis and norethindrone in the treatment.
  Scientific reports · 2025 · Ali A, Youssef A, Saman AE, et al.
  PMID 41339448DOI 10.1038/s41598-025-28540-2
• Preoperative relugolix combination therapy in laparoscopic myomectomy: a case series evaluating impact on surgical planes and operative outcomes.
  Archives of gynecology and obstetrics · 2025 · Vandermolen B, Reindorf M, McMurray R, et al.
  PMID 41186688DOI 10.1007/s00404-025-08174-5
• Norethindrone Acetate Versus Combined Oral Contraceptives in Patients With Acute Abnormal Uterine Bleeding.
  Journal of pediatric and adolescent gynecology · 2026 · Han T, Regard MM, Cardenas GA, et al.
  PMID 41151672DOI 10.1016/j.jpag.2025.10.012

The 10 most recently updated of 149 ClinicalTrials.gov registrations naming Norethindrone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial
  Recruiting · Phase 3 · Interventional · 110 enrolled · Main Line Health
  NCT06439524updated 2026-06-12
• Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)
  Withdrawn · Phase 4 · Interventional · 0 enrolled · University of Chicago
  NCT05538689updated 2026-06-05
• Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
  Recruiting · Early phase 1 · Interventional · 20 enrolled · Massachusetts General Hospital
  NCT07568509updated 2026-05-15
• Identifying Oxytocin Deficiency in Adults With Pituitary Disease
  Completed · Early phase 1 · Interventional · 28 enrolled · Elizabeth Austen Lawson
  NCT06460948updated 2026-05-13
• Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy
  Completed · Phase 3 · Interventional · 1,164 enrolled · Sumitomo Pharma Switzerland GmbH
  NCT04756037updated 2026-05-13
• A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
  Recruiting · Phase 1 · Interventional · 48 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.
  NCT07446400updated 2026-05-06
• Norethindrone Impact on Receptiva Outcomes
  Completed · Observational · 99 enrolled · Inception Fertility Research Institute, LLC
  NCT07134920updated 2026-04-15
• Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants
  Completed · Phase 1 · Interventional · 74 enrolled · Vertex Pharmaceuticals Incorporated
  NCT07074327updated 2026-03-30
• Relative Desirability of Metformin vs. Birth Control Pill in Treating PCOS in Women of Later Reproductive Age
  Withdrawn · Early phase 1 · Interventional · 0 enrolled · University of Virginia
  NCT03905941updated 2026-02-23
• Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain
  Recruiting · Phase 3 · Interventional · 130 enrolled · University of Michigan
  NCT07100782updated 2026-02-18

Frequently asked questions

How does Norethindrone work?

Mechanism-of-action class: Progestational Hormone Receptor Agonists.

What is Norethindrone used for?

According to FDA labeling, Norethindrone carries indications including: 1. Indications Progestin - only oral contraceptives are indicated for the prevention of pregnancy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Norethindrone?

Norethindrone is classified as Estren derivatives, Progestogens, Progestin, Progestational Hormone Receptor Agonists, Decreased Embryonic Implantation, Decreased Luteinizing Hormone Secretion, Gonadotropin Releasing Hormone Alteration, Inhibit Ovulation.

What are the brand names for Norethindrone?

Norethindrone is marketed under brand names including Aygestin, Combipatch, Femhrt, Fyavolv, Gallifrey, Jevantique, Jinteli, Myfembree.

What are the contraindications for Norethindrone?

Norethindrone labeling lists contraindications including: Progestin - only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy Known or suspected carcinoma of the breast Undiagnosed abnormal genital bleeding Hypersensitivity to any component of this product Benign or malignant liver tumors Acute liver disease. Always consult the full prescribing information and a clinician.