Older-generation progestogen-only pill
Updated · Methodology
First line
Contraception during breastfeeding. MEC 2015 category 1 from day 1 postpartum. Compatible with lactation, does not reduce milk supply. RID about 1–2%. Alternative to desogestrel where available.
Sources
ICD-10: Z30.0 · ICD-11: QA21
Second line
Contraception when estrogen is contraindicated and desogestrel is unavailable. Per SEGO 2023, inferior to desogestrel due to a strict 3-hour missed-dose window – higher unintended-pregnancy risk with typical use. Taken continuously at the same time.
Sources
ICD-10: Z30.0 · ICD-11: QA21
Norethisterone 350 µg daily. Acts mainly via cervical mucus and endometrium. Suppresses ovulation in only 60% of women (vs 97% for desogestrel), so the missed-dose window is strict – 3 hours. Has mild androgenic activity, may cause acne.
Discontinue if pregnant.
WHO MEC 2015 category 1. Does not reduce milk supply. RID 1–2%, Hale L2.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Verbatim lines from the interaction sections, in the language of the label
«Fenitoína, barbitúricos, bosentan, primidona, carbamazepina, rifampicina y medicamentos para el VIH ritonavir, nevirapina y efavirenz, y posiblemente también oxcarbazepina, topiramato, felbamato…»AEMPS, section 4.5 · Open on CIMA
«Los progestágenos pueden interferir en el metabolismo de otros fármacos. Por consiguiente, las concentraciones plasmáticas y tisulares de éstos pueden aumentar (p. ej., ciclosporina) o disminuir (p…»AEMPS, section 4.5 · Open on CIMA
«La relevancia clínica de las interacciones potenciales con inhibidores enzimáticos sigue siendo desconocida. Los inhibidores potentes y moderados del CYP3A4, tales como los antifúngicos azólicos (p…»AEMPS, section 4.5 · Open on CIMA
«La relevancia clínica de las interacciones potenciales con inhibidores enzimáticos sigue siendo desconocida. Los inhibidores potentes y moderados del CYP3A4, tales como los antifúngicos azólicos (p…»AEMPS, section 4.5 · Open on CIMA
«Fenitoína, barbitúricos, bosentan, primidona, carbamazepina, rifampicina y medicamentos para el VIH ritonavir, nevirapina y efavirenz, y posiblemente también oxcarbazepina, topiramato, felbamato…»AEMPS, section 4.5 · Open on CIMA
«La relevancia clínica de las interacciones potenciales con inhibidores enzimáticos sigue siendo desconocida. Los inhibidores potentes y moderados del CYP3A4, tales como los antifúngicos azólicos (p…»AEMPS, section 4.5 · Open on CIMA
«La relevancia clínica de las interacciones potenciales con inhibidores enzimáticos sigue siendo desconocida. Los inhibidores potentes y moderados del CYP3A4, tales como los antifúngicos azólicos (p…»AEMPS, section 4.5 · Open on CIMA
«La relevancia clínica de las interacciones potenciales con inhibidores enzimáticos sigue siendo desconocida. Los inhibidores potentes y moderados del CYP3A4, tales como los antifúngicos azólicos (p…»AEMPS, section 4.5 · Open on CIMA
«La relevancia clínica de las interacciones potenciales con inhibidores enzimáticos sigue siendo desconocida. Los inhibidores potentes y moderados del CYP3A4, tales como los antifúngicos azólicos (p…»AEMPS, section 4.5 · Open on CIMA
«Los progestágenos pueden interferir en el metabolismo de otros fármacos. Por consiguiente, las concentraciones plasmáticas y tisulares de éstos pueden aumentar (p. ej., ciclosporina) o disminuir (p…»AEMPS, section 4.5 · Open on CIMA
«Fenitoína, barbitúricos, bosentan, primidona, carbamazepina, rifampicina y medicamentos para el VIH ritonavir, nevirapina y efavirenz, y posiblemente también oxcarbazepina, topiramato, felbamato…»AEMPS, section 4.5 · Open on CIMA
«Fenitoína, barbitúricos, bosentan, primidona, carbamazepina, rifampicina y medicamentos para el VIH ritonavir, nevirapina y efavirenz, y posiblemente también oxcarbazepina, topiramato, felbamato…»AEMPS, section 4.5 · Open on CIMA
«Los progestágenos pueden interferir en el metabolismo de otros fármacos. Por consiguiente, las concentraciones plasmáticas y tisulares de éstos pueden aumentar (p. ej., ciclosporina) o disminuir (p…»AEMPS, section 4.5 · Open on CIMA
«Fenitoína, barbitúricos, bosentan, primidona, carbamazepina, rifampicina y medicamentos para el VIH ritonavir, nevirapina y efavirenz, y posiblemente también oxcarbazepina, topiramato, felbamato…»AEMPS, section 4.5 · Open on CIMA
«La relevancia clínica de las interacciones potenciales con inhibidores enzimáticos sigue siendo desconocida. Los inhibidores potentes y moderados del CYP3A4, tales como los antifúngicos azólicos (p…»AEMPS, section 4.5 · Open on CIMA
«La relevancia clínica de las interacciones potenciales con inhibidores enzimáticos sigue siendo desconocida. Los inhibidores potentes y moderados del CYP3A4, tales como los antifúngicos azólicos (p…»AEMPS, section 4.5 · Open on CIMA
«Anticonceptivos orales: farmacocinética de los anticonceptivos orales (1 mg de noretisterona/AEMPS, section 4.5 · Open on CIMA
«El efecto de etoricoxib sobre la farmacocinética de otros fármacos: Anticonceptivos orales: etoricoxib 60 mg administrado concomitantemente con un anticonceptivo oral que contenía 35 microgramos de…»AEMPS, section 4.5 · Open on CIMA
«Anticonceptivos orales, noretisterona y/AEMPS, section 4.5 · Open on CIMA
«Recomendaciones relativas a la a dministración simultánea: In vitro , se ha demostrado que las siguientes sustancias son potenciales inhibidores del metabolismo de tacrólimus: bromocriptina…»AEMPS, section 4.5 · Open on CIMA
«Anticonceptivos orales: Anticonceptivos orales* [ sustrato del CYP3A4; inhibidor del CYP2C19 ] Noretisterona/AEMPS, section 4.5 · Open on CIMA
«Anticonceptivos orales: En estudios clínicos con sujetos sanos, la administración en estado estacionario con zonisamida no afectó a las concentraciones séricas del etinilestradiol ni de la…»AEMPS, section 4.5 · Open on CIMA
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Important: Short summary of the official label. Does not replace the full label or clinical consultation. Label dated 11/28/2025. Source: DailyMed.
Norethindrone is approved by the FDA for the prevention of pregnancy as a progestin-only oral contraceptive, taken as one 0.35 mg tablet every day. The tablet contains no estrogen. According to the label, the first-year failure rate is 0.5% with perfect use, while with typical use it is closer to 5%, because pills are taken late or missed. Like other oral contraceptives, it does not protect against HIV infection or other sexually transmitted diseases.
Norethindrone should not be used by women who currently have a known or suspected pregnancy, known or suspected breast cancer, undiagnosed abnormal genital bleeding, hypersensitivity to any component of the product, benign or malignant liver tumors, or acute liver disease. The warnings section repeats that women with breast cancer should not use oral contraceptives, since the role of female hormones in this tumor has not been fully determined. The patient leaflet also tells women not to take the pill while using certain medicines for epilepsy or tuberculosis, such as phenytoin, carbamazepine, phenobarbital or rifampin, because they can make it less effective. Up to 10% of pregnancies reported in clinical studies of progestin-only pill users were outside the uterus, so symptoms of ectopic pregnancy should be watched for, and pregnancy or lower abdominal pain in a user should raise this possibility; a history of ectopic pregnancy, however, does not need to be treated as a contraindication. A headache or a worsening migraine with a new pattern that is recurrent, persistent or severe requires stopping the pill and looking for the cause. Other warnings and precautions in the label: the physician should stay alert to the earliest symptoms of any serious disease and stop the pill when appropriate; women who use oral contraceptives are strongly advised not to smoke; prediabetic and diabetic women should be carefully monitored; genital bleeding that suggests infection, malignancy or another abnormal condition calls for ruling out those causes, and prolonged amenorrhea calls for checking for pregnancy. Studies of long-term use of contraceptive doses of oral progestins have found no effects on fetal development, but the label considers it prudent to rule out a suspected pregnancy before starting any hormonal contraceptive. Breastfeeding is not listed as a contraindication. Small amounts of progestin pass into breast milk, giving steroid levels in infant plasma of 1–6% of maternal levels; isolated post-marketing cases of decreased milk production have been reported, and adverse effects in the infant, including jaundice, have been reported very rarely.
The regimen is one 0.35 mg tablet by mouth every day at the same time, taken continuously: each new pack starts the day after the previous one ends, with no break between packs, and tablets are not stopped during bleeding episodes. For maximum contraceptive effectiveness, the tablet must be taken exactly as directed. The patient instructions, to which the dosing section refers, advise starting on the first day of the menstrual period; if the first tablet is taken on any other day, a backup method such as condoms or spermicide is needed for the next 48 hours. After a miscarriage or abortion the tablets can be started the next day. Women switching from a combined pill take the first tablet the day after the last active combined tablet and skip the inactive ones. Women who fully breastfeed may start 6 weeks after delivery, and those who partially breastfeed should start by 3 weeks after delivery. If a tablet is taken 3 or more hours late or one or more are missed, the missed tablet is taken as soon as remembered, the usual time is resumed, and a backup method is used for 48 hours; the same 48-hour backup applies after vomiting soon after a dose. A pregnancy test should be done if a period is late after one or more late or missed tablets and sex without a backup method, and whenever two periods in a row are missed. Use before menarche is not indicated, and safety and efficacy are expected to be the same in postpubertal adolescents under 16 as in users aged 16 and older.
Norethisterone is evaluated for the following indications with varying evidence strength: Contraception during breastfeeding (evidence tier A), Contraception (evidence tier B). See the full indication matrix with dosing and citations above on this page.
Common side effects of Norethisterone (≥ 1 in 100): Irregular bleeding, Amenorrhea, Acne, Breast tenderness, Headache. See the Safety section for uncommon and serious reactions.
Discontinue if pregnant.
WHO MEC 2015 category 1. Does not reduce milk supply. RID 1–2%, Hale L2.
Norethisterone is contraindicated in: Hypersensitivity; Pregnancy; Active VTE; Severe liver disease; Breast cancer. Full list in the Safety section.
Direct links to regulator labels. Open in a new tab.
Progesterone, micronized, Red clover (Trifolium pratense), Tibolone, Tongkat ali (Eurycoma longifolia), Ulipristal acetate, Dydrogesterone, Ethinylestradiol + Desogestrel, Follitropin alfa