Plain-language summary, compiled from the cited regulatory records
Norethindrone is a progestin medication [1]. It belongs to the drug class of progestogens [1].
This medication is approved for use as a progestin-only oral contraceptive to prevent pregnancy [1]. When used perfectly, the failure rate for progestin-only oral contraceptives in the first year is 0.5%. However, the typical failure rate is estimated to be around 5% due to factors such as late or omitted pills [1].
Norethindrone is available under various brand names, including Incassia, Aranelle, and Nortrel 28 Day [1]. In the past 12 months, there have been 974 adverse event reports associated with this active ingredient [2]. The most frequently reported adverse events include off-label use, nausea, headache, drug ineffectiveness, and issues related to product dose omission [2].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 22, 2026[1]
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with a uterus. HRT for oestrogen deficiency in women at least 12 months since the last menstrual period. Experience treating women older than 65 years is limited.
How to take
GB
CACanada· Health Canada
9 products
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
JENCYCLA 28-Tablet Regimen:
The dosage of JENCYCLA tablets is one tablet daily without interruption for 28 days. 28- Day Package Starting Progestin-Only Pills 1. For the initial cycle of therapy, patients should start treatment from day 1H up to and including day 5 of their menstrual period.
Then they should continue taking one tablet every day until their package is empty. Without missing a day, they should start taking JENCYCLA from a new package. H If the first progestin-only pill is taken on another day, it is recommended that an additional method of birth control (such as latex or polyurethane condoms and spermicidal foam or gel) be used every time the patient has sex during the next 48 hours.
2. If the patient has had a miscarriage or an abortion, she can start progestin-only pills the next day. 3. Patients should take one pill at the same time every day for 28 days. After finishing a pack, they should begin a new pack the next day, NOT MISSING ANY DAYS ON THE PILLS.
USUnited States· FDA
8 products
Uses
USOfficial regulatory label· revised January 31, 2026[3]
INDICATIONS AND USAGE 1. Indications Progestin-only oral contraceptives are indicated for the prevention of pregnancy. 2. 3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.
Table 1:
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.
Emergency Contraception:
Emergency contraceptive pills or insertion of a copper intrauterine contraceptive after unprotected intercourse substantially reduces the risk of pregnancy. ). ).
Source:
Trussell J. Contraceptive Efficacy. In Hatcher RA, Trussell J, Nelson AL, Cates W, Kowal D, Policar M.
Drug interactions
Known interactions involving Norethindrone. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 288. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 02441306 · revised March 22, 2025
[3]FDA DailyMed · 0d2f8fea-3675-40… · revised January 31, 2026 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Estradot Conti provides a continuous combined treatment with oestrogen and progestagen. Posology The oestrogen and the progestagen are given every day without interruption. Estradot Conti should be applied twice weekly, every three to four days.
Each patch should be applied to a different site. In women who are not taking HRT or women who switch from a continuous combined HRT, treatment may be started on any convenient day. In women transferring from a cyclic or continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen.
4). Thus, treatment should be started with the lower dose of Estradot Conti 30 μg/95 μg. If satisfactory control of symptoms is not obtained after 3 months of treatment, the dose may be increased with application of Estradot Conti 40 μg /130 μg.
Pediatric population There is no relevant use of Estradot Conti in the paediatric population. Method of administration Each patch should be applied to a different site. Recommended application sites are clean, free from any cream, dry and intact areas of skin on the dorsal region of the hip.
The site selected should be one at which little wrinkling of the skin occurs during movement of the body. Estradot Conti must not be applied on or near the breasts. The patch should not be exposed to the sun for long periods of time.
Once in place, the patch should be covered by the clothing. Immediately before use, the sachet is to be ripped open carefully at the incision close to the bag edge, and the patch is removed without damaging it (please note that the drying agent and oxygen absorber firmly attached to the inner surface of the sachet is for assuring product quality and not to be applied to the skin).
Caution should be exercised in bending the patch up and down at the perforation until the major part of the protective liner comes off the adhesive area. The free adhesive area is stuck to an intact, cleaned skin area on the back part of the hip.
Slightly lift the smaller part of the transdermal patch, so that the remainder of the protective liner can be removed and the patch affixed completely. Once the patch has been put on completely, pressure should be exercised with the palm for about one minute.
Any touching of the adhesive area should be avoided. Taking a shower or having a bath is possible with the patch. If the patch is correctly applied, it will adhere to the skin for the required dosing period without problems. In the event that a patch does come off, it should be replaced with a new patch for the rest of the dosing period.
The patch should then be changed again at the regular time to re-establish the patient´s routine schedule. Similarly, if the patch is not changed on the scheduled day, it should be replaced as soon as possible and changed again on the next scheduled day.
Forgetting a dose may increase the likelihood of break-through bleeding and spotting. 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[1]
The most frequent reported undesirable effects during treatment with Estradiol/Norethisterone acetate were breast tenderness and pain, reactions at the application site, dysmenorrhoea, irregular bleeding, and headache. Adverse events are listed below by system organ class and frequency.
The following undesirable effects may occur during treatment with Estradiol/Norethisterone acetate: Organ system Very common (≥ Common (≥ Uncommon (≥ Rare (≥ 1/10,000 Very rare Not known class 1/10) 1/100 to < 1/10) 1/1,000 to < 1/100) to < 1/1,000) (< 1/10,000) ** (cannot be estimated from the available data) Immune system disorders Hypersensitivity anaphylactic reaction Psychiatric disorders depression*, nervousness*, affect lability, mood changes libido disorder Nervous System disorders headache* dizziness*, insomnia* migraine, vertigo paresthesia Vascular disorders hypertension, varicose veins venous thromboembolis m Gastro- intestinal disorders nausea, abdominal distension*, diarrhoea*, dyspepsia*, flatulence, abdominal pain vomiting Hepatobiliary disorders gallbladder disorder, cholelithiasis jaundice cholestatic Skin and subcu- taneous tissue disorders application site reactions acne*, rash, pruritus*, dry skin, erythema skin discoloration Alopecia Musculo- skeletal and connective tissue disorders back pain*, pain in extremity* myastenia Reproductive system and breast disorders breast pain*, breast tenderness, dysmenorrhoea*, menstrual disorder* breast enlargement*, menorrhagia*, genital discharge*, irregular vaginal breast cancer uterine leiomyoma, fallopian tube cysts, endocervical polyps bleeding, uterine spasms, vaginal infection, endometrial hyperplasia General Disorders and administration site conditions pain, asthenia, oedema peripheral*, weight increased* Investigations transaminases increased (*) Adverse reactions associated to estrogen and progestagen have been found to be relatively less frequent with the lowest dosage strength (**) Reported in post-marketing experience Breast cancer risk An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestagen therapy for more than 5 years.
The increased risk in users of oestrogen-only therapy is lower than that seen in users of oestrogen-progestagen combinations. 4). Absolute risk estimations based on results of the largest randomised placebo- controlled trial (WHI-study) and the largest meta-analysis of prospective epidemiological studies are presented.
0 Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately. 8 * Taken from baseline incidence rates in England in 2015 in women with BMI 27 (kg/m2) Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
5) +4 (0 – 9) ‡When the analysis was restricted to women who had not used HRT prior to the study there was no increased risk apparent during the first 5 years of treatment: after 5 years the risk was higher than in non-users. *WHI study in women with no uterus, which did not show an increase in risk of breast cancer.
Endometrial cancer risk Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1000 women with a uterus not using HRT. 4). Depending on the duration of oestrogen-only use and oestrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from between 5 and 55 extra cases diagnosed in every 1000 women between the ages of 50 and 65.
Adding a progestagen to oestrogen-only therapy for at least 12 days per cycle can prevent this increased risk. 2)). 4). 56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
e. deep vein thrombosis […]
GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[1]
For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.
Medical examination/follow-up Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. 4, Special warnings and precautions for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman.
Women should be advised what changes in their breasts should be reported to their doctor or nurse (see “Breast cancer” below). g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Conditions which need supervision If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised. g. liver adenoma) • Diabetes mellitus with or without vascular involvement • Cholelithiasis • Migraine or (severe) headache • Systemic lupus erythematosus • A history of endometrial hyperplasia (see below) • Epilepsy • Asthma • Otosclerosis Reasons for immediate withdrawal of therapy: Therapy should be discontinued in case a contraindication is discovered and in the following situations: • Jaundice or deterioration in liver function • Significant increase in blood pressure • New onset of migraine-like headache • Pregnancy Endometrial hyperplasia and carcinoma In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.
8). After stopping treatment risk may remain elevated for at least 10 years. The addition of a progestagen cyclically for at least 12 days per month/28 day cycle or continuous combined oestrogen-progestagen therapy in non-hysterectomised women prevents the excess risk associated with oestrogen-only HRT.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 22, 2026[1]
g. g. g. 1
This is not medical advice. Consult a qualified healthcare professional.
Their period should occur during the last seven days of using the pill pack. JENCYCLA tablets are taken every day, even when patients are having some menstrual bleeding. Breast-feeding 1. For women who are fully breast-feeding (not giving their babies any food or formula), they may start taking JENCYCLA tablets 6 weeks after delivery.
2. For women who are partially breast-feeding (giving their babies some food or formula), they should start taking JENCYCLA tablets 3 weeks after delivery. JENCYCLA Page 12 of 32 Switching Pills 1. To switch from 21-Day combined oral contraceptive pills to progestin-only pills, patients should start taking their first JENCYCLA tablet (progestin-only pill) the day after they finish the last active combined pill.
To switch from a 28-Day combined oral contraceptive regimen, patients should not take any of the 7 inactive pills from the combined pill pack. Many women have irregular periods after switching to progestin-only pills, but this is normal and to be expected.
2. For women who switch from progestin-only pills to combined pills, the first active combined pill is taken on the first day of their period, even if their progestin-only pill pack is not finished. 3. If the patient is breast-feeding, she can switch to another method of birth control at any time, except she should not switch to the combined pills until she has stopped breast- feeding or at least until 6 months after delivery.
Administration It is recommended that JENCYCLA tablets be taken at the same time every day until the pack is empty. Progestin-only pills must be taken at the same time every day since their action is time dependent. When the pack is finished after 28 days, the next pack is started ON THE NEXT DAY.
Women are not to wait any days between packs. Vomiting and/or diarrhea may reduce absorption of oral contraceptives resulting in decreased serum concentrations and therefore may reduce contraceptive efficacy. Physicians should advise patients of the need for a backup contraceptive method in the case of such gastrointestinal symptoms.
For women who take other drugs or herbal products concurrently, the pill may not work as well. See the Drug Interactions section, for a list of drugs that may decrease the effectiveness of JENCYCLA or increase breakthrough bleeding.
They should be advised to use a backup method, until they can check for possible drug interactions with their doctor or clinic. Missed Dose If a patient is more than 3 hours late taking her progestin-only pill, she should take the missed pill as soon as she remembers then go back to taking progestin-only pills at her regular time.
Inform patients to use a backup method, every time they have sex, for 48 hours after missing a pill. If patients forget more than one pill two months in a row, talk to them about ways to make pill taking easier or about using another method of birth control.
JENCYCLA Page 13 of 32 Counselling 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; the importance of using an effective barrier method in addition to progestin-only oral contraceptives if a woman is at risk of contracting or transmitting STIs/HIV.
42 g/mol Structural formula: DESCRIPTION Norethindrone is a white to creamy-white, odourless, crystalline powder with a melting range of 202°C - 208°C. It is practically insoluble in water, soluble in chloroform and in dioxan, sparingly soluble in alcohol and slightly soluble in ether.
35 mg norethindrone. 1 Aluminium Lake, lactose anhydrous, magnesium stearate, povidone K30 and sodium starch glycolate. STORAGE RECOMMENDATIONS Store between 15°C - 30°C. Leave contents in protective packaging until time of use. 35 mg norethindrone JENCYCLA Page 15 […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
Adverse reactions reported with the use of progestin-only pills include: Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding is 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. Decreased lactation has been reported very rarely.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The safety of norethindrone was evaluated in 3,099 subjects in two clinical trials. 35 mg/day administered on 21 days per cycle.
Adverse drug reactions (ADRs) reported for ≥1% of norethindrone -treated subjects are shown in Table 2. 0 ADRs reported by <1% of norethindrone -treated subjects (N=3099) in the above clinical trials are shown in Table 3. JENCYCLA Page 10 of 32 Table 3 - Adverse Drug Reactions Reported by <1% of norethindrone - treated Subjects in Two Clinical Trials of norethindrone System/Organ Class Adverse Reaction Psychiatric Disorders Depression Nervousness Gastrointestinal Disorders Gastrointestinal disorder Skin and Subcutaneous Tissue Disorders Acne Hirsutism Musculoskeletal and Connective Tissue Disorders Pain in extremity Reproductive System and Breast Disorders Genital discharge General Disorders and Administration Site Conditions Edema Post-Market Adverse Drug Reactions Adverse drug reactions first identified during post-marketing experience with norethindrone are included in Table 4.
Table 4 - Adverse Drug Reactions Identified During Post-Marketing Experience with Norethindrone from Spontaneous Reporting Immune System Disorders Anaphylactic/Anaphylactoid reaction, Hypersensitivity Gastrointestinal Disorders Abdominal pain Hepatobiliary Disorders Hepatitis, Jaundice cholestatic Skin and Subcutaneous Tissue Disorders Alopecia, Rash, Rash pruritic Pregnancy, Puerperium and Perinatal Conditions Ectopic pregnancy Reproductive System and Breast Disorders Breast pain, Menstruation delayed, Menstruation irregular, Ovarian cyst, Suppressed lactation, Vaginal hemorrhage, Menorrhagia, Withdrawal bleed when product is stopped TREATMENT OF OVERDOSE OR ACCIDENTAL INGESTION In case of overdose or accidental ingestion by children, the physician should observe the patient closely although generally no treatment is required.
There have been no reports of serious ill effects from overdosage. Overdosage may cause nausea and vomiting and withdrawal bleeding may occur in females. There are no antidotes and treatment should be symptomatic. For management of a suspected drug overdose, contact your regional Poison Control Centre.
JENCYCLA Page 11 of 32 DOSAGE AND ADMINISTRATION JENCYCLA 28-Tablet Regimen:
The dosage of JENCYCLA tablets is one tablet daily without interruption for 28 days. 28- Day Package Starting Progestin-Only Pills 1. For the initial cycle of therapy, patients should start treatment from day 1H up to and including day 5 of their menstrual period.
Then they should continue taking one tablet every day until their package is empty. Without missing a day, they should start taking JENCYCLA from a new package. H If the first progestin-only pill is taken on another day, it is recommended that an additional method of birth control (such as latex or polyurethane condoms and spermicidal foam or gel) be used every time the patient has sex during the next 48 hours.
2. If the patient has had a miscarriage or an abortion, she can start progestin-only pills the next day. 3. Patients should take one pill at the same time every day for 28 days. After finishing a pack, they should begin a new pack the next day, NOT MISSING ANY DAYS ON THE PILLS.
Their period should occur during the last seven days of using the pill pack. JENCYCLA tablets are taken every day, even when patients are having some menstrual bleeding. Breast-feeding 1. For women who are fully breast-feeding (not giving their babies any food or formula), they may start taking JENCYCLA tablets 6 weeks after delivery.
2. For women who are partially breast-feeding (giving their babies some food or formula), they should start taking JENCYCLA tablets 3 weeks after delivery. JENCYCLA Page 12 of 32 Switching Pills 1. To switch from 21-Day combined oral contraceptive pills to progestin-only pills, patients should start taking their first JENCYCLA tablet (progestin-only pill) the day after they finish the last active combined pill.
To switch from a 28-Day combined oral contraceptive regimen, patients should not take any of the 7 inactive pills from the combined pill pack. Many women have irregular periods after switching to progestin-only pills, but this is normal and to be expected.
2. For women who switch from progestin-only pills to combined pills, the first active combined pill is taken on the first day of their period, even if their progestin-only […]
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
Progestin-only pills should not be used by women who currently have the following conditions: 1. when pregnancy is suspected or diagnosed; 2. active liver disease or history of/or actual benign or malignant liver tumours; 3. known or suspected carcinoma of the breast; 4.
undiagnosed abnormal vaginal bleeding; 5. hypersensitivity to any component of this product. THE COMBINED BIRTH CONTROL PILL (OR “THE PILL”) CONTAINS BOTH AN ESTROGEN AND A PROGESTIN. THEREFORE, THIS PRODUCT MONOGRAPH DOES NOT DISCUSS THE SERIOUS HEALTH RISKS THAT HAVE BEEN ASSOCIATED WITH THE ESTROGEN COMPONENT OF COMBINED ORAL CONTRACEPTIVES.
g. smoking, hyperlipidemia, hypertension or obesity Migraine with focal aura Past ectopic pregnancy Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels. This risk increases with age and becomes significant in oral contraceptive users over 35 years of age.
Women should be counselled not to smoke. 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.
Health providers should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives. Delayed Follicular Atresia/Ovarian Cysts If follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle.
Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some JENCYCLA Page 4 of 32 cases they are associated with mild abdominal pain. Rarely, they may twist or rupture, requiring surgical intervention.
24) of developing breast cancer, particularly at a younger age and apparently related to duration of use. These studies have predominantly involved combined oral contraceptives and the hormonal contraceptives containing progesterone- only have not been widely used but there is data to determine that the use of POPs may also increase the risk.
A meta-analysis from 54 epidemiological studies reported that there is a small increase in the frequency of having breast cancer diagnosed in women who are currently using oral contraceptives (OCs) or had used them within the past 10 years compared to never-users.
Breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users. Breast cancer is rare among women under 40 years of age whether or not they take OCs. While the background risk increases with age, the excess number of breast cancer diagnoses in current and recent progesterone-only pill (POP) users is small in relation to the overall risk of breast cancer.
These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The most important risk factor for breast cancer in POP users is the age women discontinue the POP; the older the age at stopping, the more breast cancers are diagnosed.
Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping POP use. The evidence suggests that compared with never-users, among 10,000 women who use POPs for up to five years but stop by age 20, there would be less than one extra case of breast cancer diagnosed up to 10 years afterwards.
For those stopping by age 30 after 5 years use of the POP, there would be an estimated 2-3 extra cases (additional to the 44 cases of breast cancer per 10,000 women in this age group never exposed to oral contraceptives). For those stopping by age 40 after 5 years of use, there would be an estimated 10 extra cases diagnosed up to 10 years afterwards (additional to the 160 cases of breast cancer per 10,000 never-exposed women in this age group).
Increasing age and a strong family history are the most significant risk factors for the development of breast cancer. Other established risk factors include obesity, nulliparity, and late age for first full-term pregnancy. Women receiving OCs should be instructed in self-examination of their breasts.
They should notify their physicians whenever any masses are detected. A yearly clinical breast examination is also recommended. JENCYCLA Page 5 of 32 It is important to inform patients that users of all contraceptive pills appear to have a small increase in the risk of being diagnosed with breast cancer, compared with non-users of oral contraceptives.
Women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined. Some studies suggest that oral contraceptive use has been associated with an increase in the risk of developing cervical intraepithelial neoplasia in some populations of women.
However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behaviour and other factors. There is insufficient data to determine whether the use of progestin-only pills increases the risk of developing cervical intraepithelial neoplasia.
Vaginal Bleeding Irregular menstrual patterns are common among women […]
This is not medical advice. Consult a qualified healthcare professional.
Ardent Media, 2011. 10 100 Notes: 1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
Estimates of the probability of pregnancy during the first year of typical use for spermicides, withdrawal, fertility awareness-based methods, the diaphragm, the male condom, the oral contraceptive pill, and Depo-Provera are taken from the 1995 National Survey of Family Growth corrected for underreporting of abortion; see the text for the derivation of estimates for the other methods.
2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
See the text for the derivation of the estimate for each method. 3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. 4. The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant.
Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentage who would become pregnant within 1 year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
5. Foams, creams, gels, vaginal suppositories, and vaginal film. 6. The Ovulation and TwoDay methods are based on evaluation of cervical mucus. The Standard Days method avoids intercourse on cycle days 8 through 19. The Symptothermal method is a double-check method based on evaluation of cervical mucus to determine the first fertile day and evaluation of cervical mucus and temperature to determine the last fertile day.
7. Without spermicides. 8. With spermicidal cream or jelly. 9. ella, Plan B One-Step and Next Choice are the only dedicated products specifically marketed for emergency contraception. The label for Plan B One-Step (one dose is 1 white pill) says to take the pill within 72 hours after unprotected intercourse.
Research has shown that all of the brands listed here are effective when used within 120 hours after unprotected sex. The label for Next Choice (one dose is 1 peach pill) says to take 1 pill within 72 hours after unprotected intercourse and another pill 12 hours later.
Research has shown that both pills can be taken at the same time with no decrease in efficacy or increase in side effects and that they are effective when used within 120 hours after unprotected sex. The FDA has in addition declared the following 19 brands of oral contraceptives to be safe and effective for emergency contraception: Ogestrel (1 dose is 2 white pills), Nordette (1 dose is 4 light-orange pills), Cryselle, Levora, Low-Ogestrel, Lo/Ovral, or Quasence (1 dose is 4 white pills), Jolessa, Portia, Seasonale or Trivora (1 dose is 4 pink pills), Seasonique (1 dose is 4 light-blue-green pills), Enpresse (one dose is 4 orange pills), Lessina (1 dose is 5 pink pills), Aviane or LoSeasonique (one dose is 5 orange pills), Lutera or Sronyx (one dose is 5 white pills), and Lybrel (one dose is 6 yellow pills).
Norethindrone tablets have not been studied for and are not indicated for use in emergency contraception.
How to take
USOfficial regulatory label· revised January 31, 2026[3]
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, norethindrone 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 Detailed Patient Labeling for detailed instruction.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 974 reports total. [4]
Off Label Use 71
Nausea 69
Headache 59
Drug Ineffective 56
Product Dose Omission Issue 48
Fatigue 45
Vomiting 41
Pruritus 38
Dizziness 34
Pain 33
Diarrhoea 31
Anxiety 29
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised January 31, 2026[3]
ADVERSE REACTIONS
Adverse reactions reported with the use of POPs include: • 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. The following adverse reactions were also reported in clinical trials or during post-marketing experience: Gastrointestinal Disorders: vomiting, abdominal pain; General Disorders and Administration Site Conditions: fatigue, edema; Psychiatric Disorders: depression, nervousness; Musculoskeletal and Connective Tissue Disorders : pain in extremity; Reproductive System and Breast Disorders: genital discharge; breast pain, menstruation delayed, suppressed lactation, vaginal hemorrhage, menorrhagia, withdrawal bleed when product is stopped; Immune System Disorders: anaphylactic/anaphylactoid reaction, hypersensitivity; Hepatobiliary Disorders: hepatitis, jaundice cholestatic; Skin and Subcutaneous Tissue Disorders: alopecia, rash, rash pruritic.
USOfficial regulatory label· Warnings and precautions· revised January 31, 2026[3]
WARNINGS
Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke. Norethindrone tablets do 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 (COCs).
The healthcare professional is referred to the prescribing information of combined oral contraceptives for a discussion of those risks. The relationship between progestin-only oral contraceptives and these risks is not fully defined.
The healthcare professional 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.
Healthcare professionals should be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on progestin-only oral contraceptives. 2. Delayed Follicular Atresia/Ovarian Cysts If follicular development occurs, atresia of the follicle is sometimes delayed and the follicle may continue to grow beyond the size it would attain in a normal cycle.
Generally these enlarged follicles disappear spontaneously. Often they are asymptomatic; in some cases they are associated with mild abdominal pain. Rarely they may twist or rupture, requiring surgical intervention. 3. Irregular Genital Bleeding Irregular menstrual patterns are common among women using progestin-only oral contraceptives.
If genital bleeding is suggestive of infection, malignancy or other abnormal conditions, such nonpharmacologic causes should be ruled out. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated. 4. Carcinoma of the Breast and Reproductive Organs Some epidemiological studies of oral contraceptive users have reported an increased relative risk of developing breast cancer, particularly at a younger age and apparently related to duration of use.
These studies have predominantly involved combined oral contraceptives and there is insufficient data to determine whether the use of POPs similarly increases the risk. A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised January 31, 2026[3]
CONTRAINDICATIONS
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
This is not medical advice. Consult a qualified healthcare professional.
Breakthrough bleeding and spotting may occur during the first months of treatment. If breakthrough bleeding or spotting appears after some time on therapy or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
Breast cancer The overall evidence shows an increased risk of breast cancer in women taking combined oestrogen-progestagen or oestrogen-only HRT, that is dependent on the duration of taking HRT. 8). Oestrogen-only therapy The WHI trial found no increase in the risk of breast cancer in hysterectomised women using oestrogen-only HRT.
8). Results from a large meta-analysis showed that after stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.
HRT, especially oestrogen-progestagen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer. Ovarian cancer Ovarian cancer is much rarer than breast cancer.
Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
8). e. deep vein thrombosis or pulmonary embolism. 8). Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk. 3). Generally recognised risk factors for VTE include, use of oestrogens, older age, major surgery, prolonged immobilisation obesity (body mass index > 30 kg/m2), pregnancy/ postpartum period, systemic lupus erythematosus (SLE) and cancer.
There is no consensus about the possible role […]
This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.
Women with breast cancer should not use oral contraceptives because the role of female hormones in breast cancer has not been fully determined. Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women.
However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. There is insufficient data to determine whether the use of POPs increases the risk of developing cervical intraepithelial neoplasia.
5. Hepatic Neoplasia Benign hepatic adenomas are associated with combined oral contraceptive use, although the incidence of benign tumors is rare in the United States. Rupture of benign, hepatic adenomas may cause death through intra-abdominal hemorrhage.
Studies have shown an increased risk of developing hepatocellular carcinoma in combined oral contraceptive users. S. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.