Jencycla (norethindrone 0.35 mg)
Generic name: norethindrone tablets 0.35 mg (progestin-only oral contraceptive) · Brand names: Jencycla
Quick facts
Drug class
Progestin [EPC] (openFDA openfda.pharm_class_epc, Jencycla/norethindrone record); Progesterone Congeners [CS]
Rx or otc
Rx (DailyMed ANDA label)
Forms and strengths
- Tablets: 'Each tablet contains 0.35 mg norethindrone.' HOW SUPPLIED: 'Jencycla Tablets containing 0.35 mg of norethindrone, green colored, round, flat face, beveled edge tablets, debossed with "O23" on one side and "LU" on the other side.' Blister (NDC 68180-877-71) of 28 tablets; three blisters per carton (NDC 68180-877-73)
Common use one line
Used to prevent pregnancy (DailyMed Indications and Usage; MedlinePlus).
What it is used for
Jencycla is a progestin-only pill used to prevent pregnancy. If used perfectly, the first-year failure rate is 0.3%, and the typical failure rate is estimated to be closer to 9% because of late or omitted pills. It has not been studied for and is not indicated for emergency contraception.
Section
Indications and Usage
Source
DailyMed label; MedlinePlus
Source text (exact source wording)
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 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills.
Jencycla Tablets have not been studied for and are not indicated for use in emergency contraception.
MedlinePlus: Progestin-only (norethindrone) oral contraceptives are used to prevent pregnancy.
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 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills.
Jencycla Tablets have not been studied for and are not indicated for use in emergency contraception.
MedlinePlus: Progestin-only (norethindrone) oral contraceptives are used to prevent pregnancy.
How it works
It prevents conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.
Section
Clinical Pharmacology (mechanism)
Source
DailyMed label
Source text (exact source wording)
1. Mode of Action
Jencycla progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.
Jencycla progestin-only oral contraceptives prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.
Dosage: adults
Take one tablet every day, at the same time, with no break between pill packs. If you are more than 3 hours late or miss one or more pills, take the missed pill as soon as you remember, go back to your regular time, and use a backup method such as a condom and/or a spermicide every time you have sex for the next 48 hours. If you vomit soon after taking a pill, use a backup method for 48 hours.
Section
Dosage and Administration
Source
DailyMed label
Source text (exact source wording)
To achieve maximum contraceptive effectiveness, Jencycla 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.
Detailed Patient Labeling, IF YOU ARE LATE OR MISS TAKING YOUR POPs: If you are more than 3 hours late or you miss one or more POPs:
1) TAKE a missed pill as soon as you remember that you missed it,
2) THEN go back to taking POPs at your regular time,
3) BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.
If you vomit soon after taking a pill, use a backup method (such as a condom and/or a spermicide) for 48 hours.
Detailed Patient Labeling, IF YOU ARE LATE OR MISS TAKING YOUR POPs: If you are more than 3 hours late or you miss one or more POPs:
1) TAKE a missed pill as soon as you remember that you missed it,
2) THEN go back to taking POPs at your regular time,
3) BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.
If you vomit soon after taking a pill, use a backup method (such as a condom and/or a spermicide) for 48 hours.
Dosage: children
Safety and efficacy have been established in women of reproductive age, and are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use before menarche is not indicated.
Section
Pediatric Use
Source
DailyMed label
Source text (exact source wording)
9. Pediatric Use
Safety and efficacy of Jencycla tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
Safety and efficacy of Jencycla tablets have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of this product before menarche is not indicated.
Dosage adjustments
Drug interaction caps
Note
No dose caps stated in the sections read
Kidney
Note
The label has no renal statement.
Liver
The label lists benign or malignant liver tumors and acute liver disease as contraindications. No dose adjustment is given.
Section
Contraindications
Source
DailyMed label
Source text (exact source wording)
CONTRAINDICATIONS: ... Benign or malignant liver tumors
Acute liver disease
Acute liver disease
Elderly
Note
The label has no geriatric statement.
Missed dose
Take a missed pill as soon as you remember. If you are more than 3 hours late or miss a pill, use a backup method every time you have sex for the next 48 hours.
Section
Dosage and Administration; MedlinePlus
Source
DailyMed label; MedlinePlus (consistent)
Source text (exact source wording)
DailyMed Detailed Patient Labeling: If you are more than 3 hours late or you miss one or more POPs:
1) TAKE a missed pill as soon as you remember that you missed it,
2) THEN go back to taking POPs at your regular time,
3) BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.
If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your healthcare professional.
MedlinePlus: Take the missed dose as soon as you remember it, and go back to taking progestin-only (norethindrone) contraceptives at your regular time. If you take a dose more than 3 hours late, be sure to use a backup method of birth control for the next 48 hours.
1) TAKE a missed pill as soon as you remember that you missed it,
2) THEN go back to taking POPs at your regular time,
3) BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.
If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your healthcare professional.
MedlinePlus: Take the missed dose as soon as you remember it, and go back to taking progestin-only (norethindrone) contraceptives at your regular time. If you take a dose more than 3 hours late, be sure to use a backup method of birth control for the next 48 hours.
Overdose
The label says there have been no reports of serious ill effects from overdosage, including ingestion by children. Poison control: 1-800-222-1222.
Section
Overdosage; MedlinePlus
Source
DailyMed label; MedlinePlus
Source text (exact source wording)
DailyMed OVERDOSAGE: There have been no reports of serious ill effects from overdosage, including ingestion by children.
Detailed Patient Labeling: No serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose.
MedlinePlus: In case of overdose, call the poison control helpline at 1-800-222-1222.
Detailed Patient Labeling: No serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose.
MedlinePlus: In case of overdose, call the poison control helpline at 1-800-222-1222.
Storage
Store at 25°C (77°F). Excursions are permitted to 15° to 30°C (59° to 86°F).
Section
How Supplied (Lupin labeler-specific)
Source
DailyMed label
Source text (exact source wording)
STORAGE: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Keep out of reach of children.
Keep out of reach of children.
Boxed warning
NONEContraindications
Do not use if you currently have this condition: known or suspected pregnancy.
Name
Known or suspected pregnancy
Section
Contraindications
Source text (exact source wording)
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected pregnancy
Do not use if you currently have this condition: known or suspected carcinoma of the breast.
Name
Known or suspected carcinoma of the breast
Section
Contraindications
Source text (exact source wording)
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Known or suspected carcinoma of the breast
Do not use if you currently have this condition: undiagnosed abnormal genital bleeding.
Name
Undiagnosed abnormal genital bleeding
Section
Contraindications
Source text (exact source wording)
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Undiagnosed abnormal genital bleeding
Do not use if you currently have this condition: hypersensitivity to any component of this product.
Name
Hypersensitivity to any component of this product
Section
Contraindications
Source text (exact source wording)
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Hypersensitivity to any component of this product
Do not use if you currently have this condition: benign or malignant liver tumors.
Name
Benign or malignant liver tumors
Section
Contraindications
Source text (exact source wording)
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Benign or malignant liver tumors
Do not use if you currently have this condition: acute liver disease.
Name
Acute liver disease
Section
Contraindications
Source text (exact source wording)
Progestin-only oral contraceptives (POPs) should not be used by women who currently have the following conditions: Acute liver disease
Warnings and precautions
Cigarette smoking increases the risk of serious cardiovascular disease, and women who use oral contraceptives should be strongly advised not to smoke. The label does not contain estrogen and does not discuss the estrogen-related risks of combined pills.
Heading
Cigarette smoking
Section
Warnings/Precautions
Source text (exact source wording)
Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.
Jencycla 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 (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.
Jencycla 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 (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.
The ectopic pregnancy rate for progestin-only pill users is 5 per 1000 woman-years, and up to 10% of pregnancies reported in clinical studies of users are extrauterine. A history of ectopic pregnancy need not be considered a contraindication. Healthcare professionals should be alert to ectopic pregnancy in women who become pregnant or have lower abdominal pain.
Heading
Ectopic pregnancy
Section
Warnings/Precautions
Source text (exact source wording)
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.
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.
Ovarian cysts may rarely twist or rupture, needing surgery.
Heading
Delayed Follicular Atresia/Ovarian Cysts
Section
Warnings/Precautions
Source text (exact source wording)
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.
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.
Irregular menstrual patterns are common. If prolonged amenorrhea occurs, the possibility of pregnancy should be evaluated.
Heading
Irregular Genital Bleeding
Section
Warnings/Precautions
Source text (exact source wording)
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.
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.
Studies of mainly combined pills reported an increased relative risk of breast cancer, and there is insufficient data to determine whether progestin-only pills similarly increase the risk. Women with breast cancer should not use oral contraceptives.
Heading
Carcinoma of the Breast
Section
Warnings/Precautions
Source text (exact source wording)
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 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 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 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 oral contraceptive use is associated with an increased risk of cervical intraepithelial neoplasia, but there is insufficient data to determine whether progestin-only pills increase the risk.
Heading
Cervical neoplasia
Section
Warnings/Precautions
Source text (exact source wording)
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.
Benign hepatic adenomas and hepatocellular carcinoma are associated with combined pills, and there is insufficient data to determine whether progestin-only pills increase the risk of hepatic neoplasia.
Heading
Hepatic Neoplasia
Section
Warnings/Precautions
Source text (exact source wording)
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. However, these cancers are rare in the U.S. There is insufficient data to determine whether POPs increase the risk of developing 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. However, these cancers are rare in the U.S. There is insufficient data to determine whether POPs increase the risk of developing hepatic neoplasia.
This product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Heading
Precautions: STD protection
Section
Warnings/Precautions
Source text (exact source wording)
1. General
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Prediabetic and diabetic women in particular should be carefully monitored.
Heading
Precautions: Carbohydrate and Lipid Metabolism
Section
Warnings/Precautions
Source text (exact source wording)
3. Carbohydrate and Lipid Metabolism
Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.
Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL3 , LDL, or VLDL.
Some users may experience slight deterioration in glucose tolerance, with increases in plasma insulin but women with diabetes mellitus who use progestin-only oral contraceptives do not generally experience changes in their insulin requirements. Nonetheless, prediabetic and diabetic women in particular should be carefully monitored while taking POPs.
Lipid metabolism is occasionally affected in that HDL, HDL2, and apolipoprotein A-I and A-II may be decreased; hepatic lipase may be increased. There is usually no effect on total cholesterol, HDL3 , LDL, or VLDL.
Pregnancy and breastfeeding
Many studies have found no effects on fetal development with long-term use of contraceptive doses of oral progestins, but it is prudent to rule out suspected pregnancy before starting. In general no adverse effects were found on breastfeeding performance or infant health, but isolated cases of decreased milk production have been reported. Small amounts of progestins pass into breast milk. MedlinePlus says to call your doctor if you become pregnant while taking it.
Section
Pregnancy; Nursing Mothers; MedlinePlus
Source
DailyMed label; MedlinePlus
Source text (exact source wording)
7. Pregnancy
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.
8. Nursing Mothers
In general, no adverse effects have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.
MedlinePlus: tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. If you become pregnant while taking progestin-only (norethindrone) contraceptives, call your doctor.
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.
8. Nursing Mothers
In general, no adverse effects have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.
MedlinePlus: tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. If you become pregnant while taking progestin-only (norethindrone) contraceptives, call your doctor.
Side effects
Common
The label says menstrual irregularity is the most frequently reported side effect, and frequent and irregular bleeding are common. The label gives no percentage threshold.
Section
Adverse Reactions (no numeric threshold stated)
Source
DailyMed label
Source text (exact source wording)
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.
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.
Less common
The label says headache, breast tenderness, nausea, and dizziness are increased among users. Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.
Section
Adverse Reactions (no table or percentages stated)
Source
DailyMed label
Source text (exact source wording)
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.
Androgenic side effects such as acne, hirsutism, and weight gain occur rarely.
Serious
Label postmarketing and warnings
The label's postmarketing list includes vomiting, abdominal pain, fatigue, edema, depression, nervousness, anaphylactic/anaphylactoid reaction, hypersensitivity, hepatitis, cholestatic jaundice, alopecia and rash. Ectopic pregnancy and ovarian cysts are in the Warnings.
Section
Adverse Reactions (postmarketing list); Warnings
Source
DailyMed label
Source text (exact source wording)
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.
See Warnings (ectopic pregnancy, ovarian cysts) above.
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.
See Warnings (ectopic pregnancy, ovarian cysts) above.
Medlineplus
MedlinePlus says to call your doctor immediately for uncommon symptoms: menstrual bleeding that is unusually heavy or lasts a long time, lack of menstrual periods, and severe stomach pain.
Source
MedlinePlus Progestin-Only (norethindrone) Oral Contraceptives (Last Revised - 07/20/2024)
Source text (exact source wording)
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
menstrual bleeding that is unusually heavy or that lasts a long time
lack of menstrual periods
severe stomach pain
Combined estrogen and progestin oral contraceptives may increase the risk of getting breast cancer, endometrial cancer, and liver tumors. It is not known whether progestin-only (norethindrone) oral contraceptives also increase the risks of these conditions.
menstrual bleeding that is unusually heavy or that lasts a long time
lack of menstrual periods
severe stomach pain
Combined estrogen and progestin oral contraceptives may increase the risk of getting breast cancer, endometrial cancer, and liver tumors. It is not known whether progestin-only (norethindrone) oral contraceptives also increase the risks of these conditions.
Interactions
Drugs
Enzyme-inducing drugs or herbal products, such as efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant and St. John's wort, may decrease effectiveness or lead to breakthrough bleeding and/or contraceptive failure. Use an alternative non-hormonal or back-up method and continue back-up for 28 days after stopping the inducer.
Name
Enzyme inducers
Section
Drug Interactions
Source text (exact source wording)
Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the systemic concentrations of HCs and potentially diminish the effectiveness of HCs or increase breakthrough bleeding.
Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice or ketoconazole may increase progestin levels, including norethindrone.
Name
CYP3A4 inhibitors
Section
Drug Interactions
Source text (exact source wording)
Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the systemic concentrations of progestins, including norethindrone.
Progestin levels were significantly decreased with some HIV protease inhibitors (for example nelfinavir, ritonavir), some HCV protease inhibitors (boceprevir, telaprevir) and some NNRTIs (nevirapine, efavirenz), and significantly increased with others (indinavir, atazanavir/ritonavir, etravirine). These changes may be clinically relevant. Consult the labeling of the antiviral medicine.
Name
HIV/HCV protease inhibitors and NNRTIs
Section
Drug Interactions
Source text (exact source wording)
Significant decreases in systemic concentrations of progestin have been noted in cases of co- administration with some HIV protease inhibitors (e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir), some HCV protease inhibitors (e.g., boceprevir and telaprevir), and some non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine, efavirenz).
In contrast, significant increases in systemic exposure of the progestin have been noted in cases of co-administration with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine).
These changes may be clinically relevant in some cases.
Consult the prescribing information of anti-viral and anti-retroviral concomitant medications to identify potential interactions.
In contrast, significant increases in systemic exposure of the progestin have been noted in cases of co-administration with certain other HIV protease inhibitors (e.g., indinavir and atazanavir/ritonavir) and with other non-nucleoside reverse transcriptase inhibitors (e.g., etravirine).
These changes may be clinically relevant in some cases.
Consult the prescribing information of anti-viral and anti-retroviral concomitant medications to identify potential interactions.
If you want to use Jencycla after ulipristal acetate, do so no sooner than 5 days after taking it and use a reliable barrier method until your next menstrual period.
Name
Ulipristal acetate
Section
Drug Interactions
Source text (exact source wording)
Effectiveness of progestin-containing hormonal contraceptives and emergency contraceptive ulipristal acetate may be decreased if progestin-containing hormonal contraceptives are used within five days after ulipristal acetate dosing. Therefore, if a woman wishes to use Jencycla after using ulipristal acetate, she should do so no sooner than 5 days after the intake of ulipristal acetate and she should use a reliable barrier method for subsequent acts of intercourse until her next menstrual period.
Levels of other drugs may either increase (for example, cyclosporine) or decrease.
Name
Effects on other drugs
Section
Drug Interactions
Source text (exact source wording)
Hormonal contraceptives may affect the metabolism of other drugs. Consequently, systemic concentrations may either increase (for example, cyclosporine) or decrease. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.
Food and alcohol
Grapefruit juice is named among CYP3A4 inhibitors.
Name
Grapefruit juice
Section
Drug Interactions
Source text (exact source wording)
Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the systemic concentrations of progestins, including norethindrone.
Name
Alcohol
Other
Sex hormone-binding globulin (SHBG) and thyroxine concentrations may be decreased.
Name
Laboratory tests
Section
Drug Interactions (lab tests)
Source text (exact source wording)
5. Interactions with Laboratory Tests
The following endocrine tests may be affected by progestin-only oral contraceptive use:
Sex hormone-binding globulin (SHBG) concentrations may be decreased.
Thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG).
The following endocrine tests may be affected by progestin-only oral contraceptive use:
Sex hormone-binding globulin (SHBG) concentrations may be decreased.
Thyroxine concentrations may be decreased, due to a decrease in thyroid binding globulin (TBG).
Patient tips
Label patient information
Cigarette smoking greatly increases the chance of heart attacks and strokes, and women who use oral contraceptives are strongly advised not to smoke. Contact your healthcare professional immediately for sudden or severe pain in your lower abdomen or stomach area. Take the pill at the same time every day, start the next pack the day after the last pack is finished, and do not stop if you have spotting. Get a pregnancy test if your period is late and you took pills late or missed them and had sex without a backup method, or anytime it has been more than 45 days since the beginning of your last period. POPs do not protect against HIV (AIDS) or any other STD.
Section
Detailed Patient Labeling (Revised: September 2024 ID#: 277626)
Source
DailyMed label
Source text (exact source wording)
Detailed Patient Labeling: RISKS OF TAKING POPs: Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.
WARNING: If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your healthcare professional immediately.
POPs must be taken at the same time every day, so choose a time and then take the pill at that same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant.
Start the next pack the day after the last pack is finished. There is no break between packs.
You may have some menstrual spotting between periods. Do not stop taking your pills if this happens.
You should get a pregnancy test: If your period is late and you took one or more pills late or missed taking them and had sex without a backup method. Anytime it has been more than 45 days since the beginning of your last period.
WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as chlamydia, gonorrhea, genital warts or herpes.
WARNING: If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your healthcare professional immediately.
POPs must be taken at the same time every day, so choose a time and then take the pill at that same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant.
Start the next pack the day after the last pack is finished. There is no break between packs.
You may have some menstrual spotting between periods. Do not stop taking your pills if this happens.
You should get a pregnancy test: If your period is late and you took one or more pills late or missed taking them and had sex without a backup method. Anytime it has been more than 45 days since the beginning of your last period.
WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as chlamydia, gonorrhea, genital warts or herpes.
Medlineplus
Tell your doctor if you use tobacco products, and do not smoke while taking this medicine. Continue your normal diet unless told otherwise. After vomiting you may need a backup method for the next 48 hours. St. John's wort may interact.
Section
MedlinePlus
Source
MedlinePlus Progestin-Only (norethindrone) Oral Contraceptives (Last Revised - 07/20/2024), https://medlineplus.gov/druginfo/meds/a602008.html
Source text (exact source wording)
tell your doctor if you use tobacco products. Cigarette smoking may increase the risk of heart attacks and strokes. You should not smoke while taking this medication.
Unless your doctor tells you otherwise, continue your normal diet.
If you vomit soon after taking a progestin-only (norethindrone) oral contraceptives, you may have to use a backup method of birth control for the next 48 hours.
the following nonprescription or herbal products may interact with progrestin-only (norethindrone) oral contraceptives: St. John's wort.
Unless your doctor tells you otherwise, continue your normal diet.
If you vomit soon after taking a progestin-only (norethindrone) oral contraceptives, you may have to use a backup method of birth control for the next 48 hours.
the following nonprescription or herbal products may interact with progrestin-only (norethindrone) oral contraceptives: St. John's wort.
Alternatives
Class
Progestin [EPC]
Class source
openFDA label API openfda.pharm_class_epc (norethindrone/Jencycla record)
Indication source
DailyMed Indications and Usage (prevention of pregnancy)
Note
No recommendation of one drug over another.
Frequently asked questions
Question
What is Jencycla used for?
Answer
Jencycla is a progestin-only pill used to prevent pregnancy. It has not been studied for and is not indicated for emergency contraception.
Quote
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 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills.
Jencycla Tablets have not been studied for and are not indicated for use in emergency contraception.
MedlinePlus: Progestin-only (norethindrone) oral contraceptives are used to prevent pregnancy.
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 0.3%. However, the typical failure rate is estimated to be closer to 9%, due to late or omitted pills.
Jencycla Tablets have not been studied for and are not indicated for use in emergency contraception.
MedlinePlus: Progestin-only (norethindrone) oral contraceptives are used to prevent pregnancy.
Source section
Indications and Usage
Source
DailyMed label (Lupin Jencycla, set ID e91e7bdd-2984-4332-9b0b-04322792d7f6) and MedlinePlus where named
Question
How do I take it?
Answer
Take one tablet every day, at the same time, with no interruption between pill packs.
Quote
To achieve maximum contraceptive effectiveness, Jencycla 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.
Source section
Dosage and Administration
Source
DailyMed label (Lupin Jencycla, set ID e91e7bdd-2984-4332-9b0b-04322792d7f6) and MedlinePlus where named
Question
What if I miss a pill or am more than 3 hours late?
Answer
If you are more than 3 hours late or miss one or more pills, take the missed pill as soon as you remember, and use a backup method such as a condom and/or a spermicide every time you have sex for the next 48 hours.
Quote
DailyMed Detailed Patient Labeling: If you are more than 3 hours late or you miss one or more POPs:
1) TAKE a missed pill as soon as you remember that you missed it,
2) THEN go back to taking POPs at your regular time,
3) BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.
If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your healthcare professional.
MedlinePlus: Take the missed dose as soon as you remember it, and go back to taking progestin-only (norethindrone) contraceptives at your regular time. If you take a dose more than 3 hours late, be sure to use a backup method of birth control for the next 48 hours.
1) TAKE a missed pill as soon as you remember that you missed it,
2) THEN go back to taking POPs at your regular time,
3) BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.
If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your healthcare professional.
MedlinePlus: Take the missed dose as soon as you remember it, and go back to taking progestin-only (norethindrone) contraceptives at your regular time. If you take a dose more than 3 hours late, be sure to use a backup method of birth control for the next 48 hours.
Source section
Dosage and Administration
Source
DailyMed label (Lupin Jencycla, set ID e91e7bdd-2984-4332-9b0b-04322792d7f6) and MedlinePlus where named
Question
Does smoking matter?
Answer
The label says cigarette smoking increases the risk of serious cardiovascular disease and women who use oral contraceptives should be strongly advised not to smoke. MedlinePlus says you should not smoke while taking this medicine.
Quote
Cigarette smoking increases the risk of serious cardiovascular disease. Women who use oral contraceptives should be strongly advised not to smoke.
Jencycla 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 (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.
MedlinePlus: You should not smoke while taking this medication.
Jencycla 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 (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.
MedlinePlus: You should not smoke while taking this medication.
Source section
Warnings; MedlinePlus
Source
DailyMed label (Lupin Jencycla, set ID e91e7bdd-2984-4332-9b0b-04322792d7f6) and MedlinePlus where named
Question
What are the common side effects?
Answer
Menstrual irregularity is the most frequently reported side effect. Frequent and irregular bleeding are common. Headache, breast tenderness, nausea, and dizziness are increased among users.
Quote
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.
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.
Source section
Adverse Reactions
Source
DailyMed label (Lupin Jencycla, set ID e91e7bdd-2984-4332-9b0b-04322792d7f6) and MedlinePlus where named
Question
Can I use it while breastfeeding?
Answer
In general no adverse effects were found on breastfeeding performance or infant health, but isolated cases of decreased milk production have been reported, and small amounts of progestins pass into breast milk.
Quote
7. Pregnancy
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.
8. Nursing Mothers
In general, no adverse effects have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.
MedlinePlus: tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. If you become pregnant while taking progestin-only (norethindrone) contraceptives, call your doctor.
Many studies have found no effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted have not demonstrated significant adverse effects. It is nonetheless prudent to rule out suspected pregnancy before initiating any hormonal contraceptive use.
8. Nursing Mothers
In general, no adverse effects have been found on breastfeeding performance or on the health, growth, or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant plasma.
MedlinePlus: tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. If you become pregnant while taking progestin-only (norethindrone) contraceptives, call your doctor.
Source section
Nursing Mothers
Source
DailyMed label (Lupin Jencycla, set ID e91e7bdd-2984-4332-9b0b-04322792d7f6) and MedlinePlus where named
Question
Does it protect against sexually transmitted infections?
Answer
No. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Quote
1. General
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Source section
Precautions
Source
DailyMed label (Lupin Jencycla, set ID e91e7bdd-2984-4332-9b0b-04322792d7f6) and MedlinePlus where named
Question
Which medicines can change how it works?
Answer
The label names enzyme-inducing drugs such as efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate and griseofulvin, and CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice and ketoconazole. It also lists some HIV and HCV antivirals.
Quote
Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the systemic concentrations of HCs and potentially diminish the effectiveness of HCs or increase breakthrough bleeding.
Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the systemic concentrations of progestins, including norethindrone.
Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, and products containing St. John's wort. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the systemic concentrations of progestins, including norethindrone.
Source section
Drug Interactions
Source
DailyMed label (Lupin Jencycla, set ID e91e7bdd-2984-4332-9b0b-04322792d7f6) and MedlinePlus where named
Sources
- DailyMed Jencycla (Lupin Pharmaceuticals, Inc.), ANDA
Set id: e91e7bdd-2984-4332-9b0b-04322792d7f6 · Label effective or revised date: Revised: September 2024 (main label) and Revised: September 2024 ID#: 277626 (Detailed Patient Labeling); page footer also shows 'Revised: 12/2025' · Dailymed version date: Updated December 8, 2025 (page header); API published_date Dec 09, 2025 · Fetched at: 2026-11-02 · Sections used: Entire label captured verbatim via get_page_text (printer-friendly page, 39,073 characters) - MedlinePlus Progestin-Only (norethindrone) Oral Contraceptives
Label effective or revised date: Last Revised - 07/20/2024 · Fetched at: 2026-11-02 · Sections used: all (captured verbatim via get_page_text) - openFDA label API
Label effective or revised date: NOT FOUND · Fetched at: 2026-11-02 · Sections used: openfda.pharm_class_epc, pharm_class_cs - Drugs@FDA
Label effective or revised date: NOT FOUND · Fetched at: 2026-11-02 · Sections used: not searched; NOT FOUND
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug