Last reviewed 2026-04-20 · How we verify

Aygestin (NORETHINDRONE ACETATE)

Aygestin (Norethindrone Acetate) is a progestin medication originally developed by Warner Chilcott LLC and currently owned by Duramed Res. It targets the progesterone receptor and is used to treat various conditions including acne, contraception, and endometriosis. Aygestin is a small molecule drug that has been FDA-approved since 1973 and is now available as a generic medication. It has multiple approved indications and is off-patent, meaning it is no longer protected by active patents. As a result, it is manufactured by multiple generic manufacturers.

At a glance

Approved indications

• Acne vulgaris
• Contraception
• Dysfunctional uterine bleeding
• Endometriosis
• Secondary physiologic amenorrhea
• Uterine fibroids

Boxed warnings

• 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. For this reason, COCs, including Hailey 1.5/30, are contraindicated in women who are over 35 years of age and smoke (see CONTRAINDICATIONS and WARNINGS ). Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

Common side effects

• Thrombotic and thromboembolic events
• Optic neuritis
• Anaphylactic/anaphylactoid reactions
• Abnormalities of liver tests
• Decreased HDL cholesterol and increased LDL/HDL ratio
• Clinical depression
• Melasma or chloasma
• Mood swings
• Nausea
• Insomnia
• Headache/migraine
• Breast enlargement/tenderness

Key clinical trials

• Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants (PHASE1)
• A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together (PHASE1)
• Relative Desirability of Metformin vs. Birth Control Pill in Treating PCOS in Women of Later Reproductive Age (EARLY_PHASE1)
• Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain (PHASE3)
• Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy (PHASE3)
• Ovulation Incidence in Oral Contraceptive Users (PHASE3)
• A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia (PHASE4)
• Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.