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Norethindrone

1. Indications Progestin - only oral contraceptives are indicated for the prevention of pregnancy. 2. Efficacy If used perfectly, the first-year failu.

Checked against the official label · Updated

Prescription medicine Oral Safety alerts on record

Norethindrone: quick answers

Used for
1.
Prescription
Prescription medicine in the United States; rules differ by country.

From the official label (Sep 2021). Your prescription and pharmacist come first.

How to use Norethindrone

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is 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 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. …

How to take it and how often
  • 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
While you are taking it
  • INFORMATION FOR THE PATIENT 1
  • See PATIENT LABELING for detailed information. 2
  • Counseling Issues The following points should be discussed with prospective users before prescribing progestin-only oral contraceptives: The necessity of taking pills at the same time every day, including throughout all bleeding episodes
  • The need to use a backup method such as condoms and spermicides for the next 48 hours whenever a progestin-only oral contraceptive is taken 3 or more hours late
  • The potential side effects of progestin-only oral contraceptives, particularly menstrual irregularities
  • The need to inform the clinician of prolonged episodes of bleeding, amenorrhea or severe abdominal pain. …
Talk to a doctor first if

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

Warnings

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. …

Possible side effects

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.

If you take too much

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

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2021-09-14.

Brands around the world

Products with Norethindrone as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

Kaitlib FeKit · Lupin Pharmaceuticals, Inc.
NDC 68180-903Label
Norethindrone Acetate And Ethinyl Estradiol, And Ferrous FumarateKit · Amneal Pharmaceuticals LLC
NDC 69238-1686Label
Nortrel 7/7/7 (28 Day Regimen) (28 Day Regimen)Kit · Proficient Rx LP
NDC 71205-685Label
Estradiol And Norethindrone AcetateESTRADIOL 1 mg/1, NORETHINDRONE ACETATE .5 mg/1 · Tablet · Ingenus Pharmaceuticals, LLC
NDC 50742-657Label
GemmilyKit · Xiromed, LLC
NDC 70700-152Label

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, MU.S. FDA Class II
27 May 2026 · Glenmark Pharmaceuticals Inc., USA · OngoingFailed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTU.S. FDA Class III
25 Jan 2024 · Teva Pharmaceuticals USA, Inc · OngoingDiscoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx onlU.S. FDA Class III
25 Jan 2024 · Teva Pharmaceuticals USA, Inc · OngoingDiscoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, ManufaU.S. FDA Class III
7 Jan 2022 · Teva Pharmaceuticals USA · TerminatedMislabeling

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Norethindrone

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Norethindrone

What is Norethindrone 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 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception. Table 2: Percentage (From the official U.S. FDA label.)

How do I take Norethindrone?

Follow your prescription or the leaflet in your pack. The official label says: 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.…

Do I need a prescription for Norethindrone?

Usually yes. Norethindrone is a prescription medicine in most countries. Rules differ by country.

What brands contain Norethindrone?

Norethindrone is sold under names such as Jinteli, Jevantique, Fyavolv, Combipatch, Myfembree, Gallifrey, Femhrt, Incassia. Brand names differ between countries.

What are the side effects of Norethindrone?

The official label lists: 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 oc… Tell your doctor about any side effect that bothers you or does not go away.

What happens if I take too much Norethindrone?

There have been no reports of serious ill effects from overdosage, including ingestion by children. Get medical help right away.

How can I check that my Norethindrone is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.