ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : -46 مورد

Norgestrel: Drug information

Norgestrel: Drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Norgestrel: Patient drug information" and "Norgestrel: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Opill
Pharmacologic Category
  • Contraceptive;
  • Progestin
Dosing: Adult
Contraception

Contraception: Oral: One tablet once daily at the same time each day in the order presented in the blister pack. Do not skip days.

If not currently using a contraceptive, the first dose may be started on any day during the month. Use a condom or other barrier method of contraception for the first 2 days (48 hours) after the first dose. If switching from another contraceptive (another oral contraceptive, vaginal ring, or patch), take the first dose the day after stopping the other method.

Missed or late dose: If more than 3 hours since last dose or if missed dose completely: Take 1 tablet immediately, then continue taking 1 tablet once daily at the usual time. Use a condom or other barrier method of contraception for the first 2 days (48 hours) after the missed dose.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Not indicated for use post menopause.

Dosing: Pediatric

(For additional information see "Norgestrel: Pediatric drug information")

Contraception

Contraception: Postmenarche patients: Oral: One tablet once daily at the same time each day in the order presented in the blister pack. Do not skip days.

If not currently using a contraceptive, the first dose may be started on any day during the month. Use a condom or other barrier method of contraception for the first 2 days (48 hours) after the first dose. If switching from another contraceptive (another oral contraceptive, vaginal ring, or patch), take the first dose the day after stopping the other method.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

There are no adverse reactions listed in the manufacturer's labeling.

Contraindications

OTC labeling: When used for self-medication, do not use if allergic to norgestrel or any component of the formulation; have or ever had breast cancer; during pregnancy; concomitantly with another oral contraceptive, vaginal ring, patch, implant, injection, or an IUD (intra-uterine device); as an emergency contraceptive; or in males.

Warnings/Precautions

Concerns related to adverse effects:

• Allergic reaction: Stop taking norgestrel and contact health care provider if allergic symptoms develop. Symptoms may include asthma (wheezing), blisters, facial swelling, hives, rash, red skin, or shock.

• Bleeding irregularities: Changes in menstrual bleeding (irregular periods), spotting, or bleeding in between menstrual cycles (periods) may occur during treatment. Contact health care provider if bleeding occurs during sex, or if periods last more than 8 days or become unusually heavy. Menstrual cycles may stop during use of norgestrel. When used for self-medication (OTC labeling), contact health care provider if there is vaginal bleeding in between menstrual cycles (periods) prior to taking norgestrel.

Disease-related concerns:

• Cancer: When used for self-medication (OTC labeling), contact health care provider prior to use if you have or ever had any type of cancer.

• Hepatic impairment: When used for self-medication (OTC labeling), contact health care provider prior to use if you have liver problems.

• HIV infection: When used for self-medication (OTC labeling), contact health care provider prior to use if you are taking medications for HIV/AIDS.

• Migraine: When used for self-medication (OTC labeling), contact health care provider if you have migraine headaches that get worse, or migraine headaches with aura (vision changes) while taking norgestrel.

• Seizure: When used for self-medication (OTC labeling), contact health care provider prior to use if you are taking medications for seizures.

• Tuberculosis: When used for self-medication (OTC labeling), contact health care provider prior to use if you are taking medications for tuberculosis.

• Pulmonary hypertension: When used for self-medication (OTC labeling), contact health care provider prior to use if you are taking medications for pulmonary hypertension.

Concurrent drug therapy issues:

• St John's wort: When used for self-medication (OTC labeling), contact health care provider prior to use if taking an herbal supplement containing St John’swort.

• Ulipristal: When used for self-medication (OTC labeling), contact health care provider prior to use if you have taken ulipristal for emergency contraception (morning after pill) within the previous 5 days.

Dosage form specific issues:

• Tartrazine: Contains tartrazine (FD&C yellow #5), which may cause allergic reactions (including asthma) in susceptible individuals, particularly those with aspirin allergy.

Other warnings/precautions:

• HIV infection protection: Use does not protect against HIV infection or other sexually transmitted diseases.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Opill: 0.075 mg (28s)

Administration: Adult

Oral: Administer at the same time each day. When one pack is done, start a new pack the next day; do not skip days between starting a new pack. If severe diarrhea or vomiting occur within 4 hours after taking a tablet, use a condom or other barrier method of contraception for the next 2 days (48 hours).

Administration: Pediatric

Oral: Administer at the same time each day. When one pack is done, start a new pack the next day; do not skip days between starting a new pack. If severe diarrhea or vomiting occur within 4 hours after taking a tablet, use a condom or other barrier method of contraception for the next 2 days (48 hours).

Missed or late dose: If >3 hours late taking dose or if missed dose completely: Take 1 tablet immediately, then continue taking 1 tablet once daily at the usual time. Use a condom or other barrier method of contraception for the first 2 days (48 hours) after the missed dose.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 2]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Use: Labeled Indications

Contraception: For the prevention of pregnancy.

Limitations of use: Progestin-only contraceptives are for use in patients who may become pregnant; not for use prior to menarche or post menopause (CDC [Curtis 2016a]).

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (contraindicated in pregnancy) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).

Metabolism/Transport Effects

Substrate of CYP3A4 (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Adalimumab: May decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor

Aprepitant: May decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration with aprepitant, and to continue back-up contraception for 28 days after discontinuing aprepitant to ensure contraceptive reliability. Risk D: Consider Therapy Modification

Asparaginase Products: Hormonal Contraceptives may increase thrombogenic effects of Asparaginase Products. Management: Consider discontinuing hormonal contraceptives and using an alternative contraceptive method in patients treated with asparaginase products. Risk D: Consider Therapy Modification

Atazanavir: May decrease serum concentration of Hormonal Contraceptives. Specifically, atazanavir/ritonavir may decrease concentrations of estrogens. Atazanavir may increase serum concentration of Hormonal Contraceptives. Specifically, atazanavir alone may increase concentrations of estrogens and atazanavir alone or boosted may increase concentrations of progestins. Management: Dose adjustment of hormonal contraceptives or use of alternative or additional nonhormonal contraceptive may be needed when combined with atazanavir. See full interact monograph for details. Atazanavir/cobicistat with drospirenone is contraindicated. Risk D: Consider Therapy Modification

Bimekizumab: May decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Brigatinib: May decrease serum concentration of Hormonal Contraceptives. Management: Use a non-hormonal contraceptive during brigatinib use and for at least 4 months after the last brigatinib dose. Males with partners of reproductive potential should use contraception during treatment with brigatinib and for 3 months after brigatinib use. Risk D: Consider Therapy Modification

Carfilzomib: Hormonal Contraceptives may increase thrombogenic effects of Carfilzomib. Management: Consider alternative, non-hormonal methods of contraception in patients requiring therapy with carfilzomib, especially patients using carfilzomib in combination with dexamethasone, lenalidomide plus dexamethasone, or daratumumab plus dexamethasone. Risk D: Consider Therapy Modification

Chlorprothixene: Progestins may increase therapeutic effects of Chlorprothixene. Progestins may increase adverse/toxic effects of Chlorprothixene. Risk C: Monitor

Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor

Cobicistat: May decrease serum concentration of Hormonal Contraceptives. Specifically, cobicistat may decrease serum concentrations of estrogens. Cobicistat may increase serum concentration of Hormonal Contraceptives. Specifically, cobicistat may increase serum concentrations of progestins. Management: Use alternative or additional nonhormonal forms of contraception when estrogen-containing hormonal contraceptives are combined with cobicistat. Progestin-only contraceptives can be used without back up, but monitor for progestin toxicities. Risk D: Consider Therapy Modification

Colchicine: May increase adverse/toxic effects of Hormonal Contraceptives. Risk C: Monitor

CYP3A4 Inducers (Moderate): May decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a moderate CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider Therapy Modification

CYP3A4 Inducers (Strong): May decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a strong CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider Therapy Modification

CYP3A4 Inducers (Weak): May decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a weak CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Strong): May increase serum concentration of Hormonal Contraceptives. Risk C: Monitor

Deferasirox: May decrease serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Efavirenz: May decrease serum concentration of Hormonal Contraceptives. Management: Use a back-up method during coadministration, and to continue back-up contraception for 12 weeks after stopping efavirenz to ensure contraceptive reliability. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Risk D: Consider Therapy Modification

Elafibranor: May decrease serum concentration of Hormonal Contraceptives. Risk X: Avoid

Elagolix: Hormonal Contraceptives may decrease therapeutic effects of Elagolix. Specifically, estrogen-containing hormonal contraceptives may diminish the therapeutic effects of elagolix. Elagolix may decrease serum concentration of Hormonal Contraceptives. Specifically, concentrations of progestins may be decreased with elagolix therapy. Elagolix may increase serum concentration of Hormonal Contraceptives. Specifically, concentrations of ethinyl estradiol may be increased with elagolix therapy. Management: Use an alternative, nonhormonal contraceptive during treatment with elagolix and for at least 28 days following discontinuation of elagolix treatment. Use of elagolix 200 mg twice daily with an estrogen-containing hormonal contraceptive is not recommended Risk D: Consider Therapy Modification

Elexacaftor, Tezacaftor, and Ivacaftor: Hormonal Contraceptives may increase adverse/toxic effects of Elexacaftor, Tezacaftor, and Ivacaftor. Specifically, the risk for rash may be increased. Risk C: Monitor

Encorafenib: May decrease serum concentration of Hormonal Contraceptives. Risk X: Avoid

Etravirine: May decrease serum concentration of Hormonal Contraceptives. Specifically, progestin concentrations may decrease. Etravirine may increase serum concentration of Hormonal Contraceptives. Specifically, estrogen concentrations may increase. Risk C: Monitor

Exenatide: Hormonal Contraceptives may decrease therapeutic effects of Exenatide. Exenatide may decrease serum concentration of Hormonal Contraceptives. Management: Administer oral hormonal contraceptives at least one hour prior to exenatide. Monitor blood glucose more frequently when patients treated with exenatide initiate therapy with a hormonal contraceptive. Increases in exenatide doses may be needed. Risk D: Consider Therapy Modification

Felbamate: May decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing felbamate to ensure contraceptive reliability. Risk D: Consider Therapy Modification

Flibanserin: Hormonal Contraceptives may increase serum concentration of Flibanserin. Risk C: Monitor

Fosaprepitant: May decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration with fosaprepitant, and to continue back-up contraception for 28 days after discontinuing fosaprepitant to ensure contraceptive reliability. Risk D: Consider Therapy Modification

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Griseofulvin: May decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing griseofulvin to ensure contraceptive reliability. Risk D: Consider Therapy Modification

Interleukin-6 (IL-6) Inhibiting Therapies: May decrease serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Ivosidenib: May decrease serum concentration of Hormonal Contraceptives. Management: Consider alternative methods of contraception (ie, non-hormonal) in patients receiving ivosidenib. Risk D: Consider Therapy Modification

Ixazomib: May decrease serum concentration of Hormonal Contraceptives. More specifically, use of ixazomib with dexamethasone may decrease the serum concentrations of hormonal contraceptives. Management: Patients of reproductive potential should use a non-hormonal contraceptive method during treatment with ixazomib and for at least 90 days after the last ixazomib dose. Risk D: Consider Therapy Modification

Levomethadone: Hormonal Contraceptives may increase serum concentration of Levomethadone. Risk C: Monitor

Lixisenatide: Hormonal Contraceptives may decrease therapeutic effects of Lixisenatide. Lixisenatide may decrease serum concentration of Hormonal Contraceptives. Management: Administer oral hormonal contraceptives 1 hour before or at least 11 hours after administration of lixisenatide. Additionally, monitor blood glucose more frequently when patients treated with lixisenatide initiate therapy with a hormonal contraceptive. Risk D: Consider Therapy Modification

Mavacamten: May decrease serum concentration of Hormonal Contraceptives. Management: Use with ethinyl estradiol/norethindrone is permitted. With other hormonal contraceptives, use a back-up (eg, condoms) or alternative (eg, IUD) method during coadministration, and to continue back-up contraception for 4 months after stopping mavacamten. Risk D: Consider Therapy Modification

MetyraPONE: Coadministration of Progestins and MetyraPONE may alter diagnostic results. Management: Consider alternatives to the use of the metyrapone test in patients taking progestins. Risk D: Consider Therapy Modification

MiFEPRIStone: May decrease therapeutic effects of Hormonal Contraceptives. Management: Nonhormonal contraception should be used during, and for 4 weeks following, mifepristone treatment for hyperglycemia due to Cushing syndrome. If used for pregnancy termination, hormonal contraceptives can be used after pregnancy expulsion is confirmed. Risk D: Consider Therapy Modification

Mirikizumab: May decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Mitotane: May decrease serum concentration of Hormonal Contraceptives. Management: Effective nonhormonal contraception is recommended for those of reproductive potential during treatment with mitotane as well as after discontinuation of mitotane for as long as mitotane plasma levels are detectable. Risk X: Avoid

Mobocertinib: May decrease serum concentration of Hormonal Contraceptives. Risk X: Avoid

Mycophenolate: May decrease serum concentration of Hormonal Contraceptives. Management: Patients of childbearing potential who are taking hormonal contraceptives should use an additional form of barrier contraception during treatment with mycophenolate and for 6 weeks after mycophenolate discontinuation. Risk D: Consider Therapy Modification

Nemolizumab: May decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Nirmatrelvir and Ritonavir: May decrease serum concentration of Hormonal Contraceptives. Specifically, nirmatrelvir and ritonavir may decrease concentrations of estrogens. Nirmatrelvir and Ritonavir may increase serum concentration of Hormonal Contraceptives. Specifically, nirmatrelvir and ritonavir may increase concentrations of progestins. Management: Use additional nonhormonal forms of contraception (back-up method) when estrogen-containing hormonal contraceptives are combined with nirmatrelvir/ritonavir. Progestin-only contraceptives can be used without back-up, but monitor for progestin toxicities. Risk D: Consider Therapy Modification

Octreotide: May decrease serum concentration of Hormonal Contraceptives. Management: Women should use an alternative non-hormonal method of contraception or a back-up method when octreotide is combined with hormonal contraceptives. Risk D: Consider Therapy Modification

Olutasidenib: May decrease serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Management: Avoid use of olutasidenib with sensitive or narrow therapeutic index CYP3A4 substrates when possible. If concurrent use with olutasidenib is unavoidable, monitor closely for evidence of decreased concentrations of the CYP3A4 substrates. Risk D: Consider Therapy Modification

Omaveloxolone: May decrease serum concentration of Hormonal Contraceptives. Risk X: Avoid

OXcarbazepine: May decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing oxcarbazepine to ensure contraceptive reliability. Risk D: Consider Therapy Modification

Pacritinib: May decrease serum concentration of Hormonal Contraceptives. Management: Avoid use of hormonal contraceptives with pacritinib, except for intrauterine systems containing levonorgestrel. If contraception is needed, use a nonhormonal contraceptive or an intrauterine system for at least 30 days after the last dose of pacritinib. Risk D: Consider Therapy Modification

Perampanel: May decrease serum concentration of Hormonal Contraceptives. Management: Patients should use an alternative, nonhormonal-based form of contraception during the concurrent use of perampanel and for 1 month after discontinuing perampanel. Risk D: Consider Therapy Modification

Pexidartinib: May decrease serum concentration of Hormonal Contraceptives. Risk X: Avoid

Pitolisant: May decrease serum concentration of Hormonal Contraceptives. Management: Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with pitolisant and for at least 21 days after discontinuation of pitolisant treatment. Risk D: Consider Therapy Modification

Protease Inhibitors: May decrease serum concentration of Hormonal Contraceptives. Specifically, protease inhibitors may decrease concentrations of estrogens. Protease Inhibitors may increase serum concentration of Hormonal Contraceptives. Specifically, protease inhibitors may increase concentrations of progestins. Management: Use alternative or additional nonhormonal forms of contraception when estrogen-containing hormonal contraceptives are combined with protease inhibitors. Progestin-only contraceptives can be used without back up, but monitor for progestin toxicities. Risk D: Consider Therapy Modification

Repotrectinib: May decrease serum concentration of Hormonal Contraceptives. Risk X: Avoid

Retinoic Acid Derivatives: May decrease therapeutic effects of Progestins (Contraceptive). Retinoic Acid Derivatives may decrease serum concentration of Progestins (Contraceptive). Management: Two forms of effective contraception should be used in patients receiving retinoic acid derivatives. Microdosed progesterone-only preparations (ie, minipills that do not contain estrogen) are considered an inadequate method of contraception. Risk D: Consider Therapy Modification

Sugammadex: May decrease therapeutic effects of Hormonal Contraceptives. Management: Patients receiving any hormonal contraceptive (oral or non-oral) should use an additional, nonhormonal contraceptive method during and for 7 days following sugammadex treatment. Risk D: Consider Therapy Modification

Suzetrigine: May decrease serum concentration of Hormonal Contraceptives. Management: Patients should use a nonhormonal contraceptive, an intrauterine system, or ethinyl estradiol and norethindrone or levonorgestrel for the duration of treatment with suzetrigine and for 28 days after stopping suzetrigine. Risk D: Consider Therapy Modification

Taurursodiol: May decrease serum concentration of CYP3A4 Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk X: Avoid

Tazemetostat: May decrease serum concentration of Hormonal Contraceptives. Management: Individuals of childbearing potential should use a non-hormonal contraceptive method during treatment with tazemetostat and for 6 months after. Males with partners of childbearing potential should use contraception during treatment and for 3 months after. Risk D: Consider Therapy Modification

Tetrahydrocannabinol and Cannabidiol: May decrease serum concentration of Hormonal Contraceptives. Management: Product labeling recommends that patients taking hormonal contraceptives should use an additional, non-hormonal contraceptive or reliable barrier method during treatment with THC/CBD buccal spray. Other forms of THC and CBD do not contain this warning. Risk D: Consider Therapy Modification

Thalidomide: Hormonal Contraceptives may increase thrombogenic effects of Thalidomide. Risk C: Monitor

Tirzepatide: May decrease serum concentration of Hormonal Contraceptives. Management: Patients using oral hormonal contraceptives should switch to a non-oral contraceptive method, or add a barrier method of contraception, for 4 weeks after initiation of tirzepatide and for 4 weeks after each dose escalation of tirzepatide. Risk D: Consider Therapy Modification

Topiramate: May decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing topiramate to ensure contraceptive reliability. Risk D: Consider Therapy Modification

Tovorafenib: May decrease serum concentration of Hormonal Contraceptives. Management: Avoid concurrent use when possible. If combined use is unavoidable, use of an additional nonhormonal method of contraception is recommended during combined use and for 28 days after stopping tovorafenib. Risk D: Consider Therapy Modification

Tranexamic Acid: Hormonal Contraceptives may increase thrombogenic effects of Tranexamic Acid. Risk X: Avoid

Ulipristal: May decrease therapeutic effects of Progestins. Progestins may decrease therapeutic effects of Ulipristal. Risk X: Avoid

Ustekinumab: May decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Vaborbactam: May decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing meropenem/vaborbactam to ensure contraceptive reliability. Risk D: Consider Therapy Modification

Vedolizumab: May decrease serum concentration of CYP Substrates (Narrow Therapeutic Index/Sensitive with Inducers). Risk C: Monitor

Vitamin K Antagonists: Hormonal Contraceptives may increase serum concentration of Vitamin K Antagonists. Hormonal Contraceptives may decrease serum concentration of Vitamin K Antagonists. Risk C: Monitor

Vorasidenib: May decrease serum concentration of Hormonal Contraceptives. Management: Avoid combined use when possible, but if this combination cannot be avoided, use of an alternative, nonhormonal means of contraception is recommended during treatment with vorasidenib and for 3 months after the last dose. Risk D: Consider Therapy Modification

Voriconazole: Hormonal Contraceptives may increase serum concentration of Voriconazole. Voriconazole may increase serum concentration of Hormonal Contraceptives. Risk C: Monitor

Reproductive Considerations

When used for self-medication (OTC labeling), the manufacturer recommends taking a pregnancy test or contacting a health care provider if a menstrual period is late after missing any tablets during the month, if there are no menstrual periods for 2 months, or anytime a pregnancy is suspected.

Use a condom or other barrier method of contraception for the first 2 days (48 hours) after the first dose, if a tablet is missed or taken more than 3 hours late, or if severe nausea or vomiting occur after a dose.

This product is not for use as emergency contraception; it does not prevent pregnancy if used after unprotected sex.

Progestin-only contraceptives may be started immediately postpartum (CDC [Curtis 2016a]; CDC [Curtis 2016b]). A rapid return to fertility is expected if norgestrel is discontinued.

All available forms of contraception can be considered for patients on gender affirming testosterone therapy after evaluating patient preferences and medical conditions (eg, risk for venous thromboembolism) (Bonnington 2020; Krempasky 2020).

Pregnancy Considerations

When used for self-medication (OTC labeling), norgestrel is used to prevent pregnancy; norgestrel should not be used in people who are pregnant or think they may be pregnant. When used for self-medication (OTC labeling), patients should discontinue norgestrel and contact health care provider if pregnancy occurs.

Breastfeeding Considerations

Progestins are present in breast milk.

When used for self-medication (OTC labeling), norgestrel is acceptable for use in people who wish to breastfeed. Available guidelines state progestin-only contraceptives may be started at any time postpartum in breastfeeding patients (CDC [Curtis 2016a]; CDC [Curtis 2016b]).

Monitoring Parameters

Self-medication (OTC labeling): Instruct patients to discontinue norgestrel and/or contact a health care provider immediately if the following occur: pain in lower belly (mostly on one side), yellowing of skin or whites of eyes, fever, tiredness, loss of appetite, dark colored urine, late menstrual period after missing any tablets during the month, no menstrual period for 2 months, or any time a pregnancy is suspected.

Mechanism of Action

Progestin-only contraceptive tablets prevent pregnancy through several mechanisms: Thickening of cervical mucus, which inhibits sperm passage through the uterus; inhibition of sperm survival; alteration of the endometrium. Inhibition of ovulation may also occur in some patients (McCann 1994).

Pharmacokinetics (Adult Data Unless Noted)

Time to peak: 2 hours (Warren 1974).

  1. Bonnington A, Dianat S, Kerns J, et al. Society of Family Planning clinical recommendations: contraceptive counseling for transgender and gender diverse people who were female sex assigned at birth. Contraception. 2020;102(2):70-82. doi:10.1016/j.contraception.2020.04.001 [PubMed 32304766]
  2. Curtis KM, Jatlaoui TC, Tepper NK, et al. US selected practice recommendations for contraceptive use, 2016. MMWR Recomm Rep. 2016a;65(4):1‐66. doi:10.15585/mmwr.rr6504a1 [PubMed 27467319]
  3. Curtis KM, Tepper NK, Jatlaoui TC, et al. US medical eligibility criteria for contraceptive use, 2016. MMWR Recomm Rep. 2016b;65(3):1‐103. doi:10.15585/mmwr.rr6503a1 [PubMed 27467196]
  4. Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
  5. Krempasky C, Harris M, Abern L, Grimstad F. Contraception across the transmasculine spectrum. Am J Obstet Gynecol. 2020;222(2):134-143. doi:10.1016/j.ajog.2019.07.043 [PubMed 31394072]
  6. McCann MF, Potter LS. Progestin-only oral contraception: a comprehensive review. Contraception. 1994;50(6 suppl 1):S1-S195. [PubMed 10226677]
  7. Opill (norgestrel) [prescribing information]. Allegan, MI: PMI Branded Pharmaceuticals Inc; received March 2024.
  8. Ovesen JL, Sam­mons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  9. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
  10. Warren RJ, Fotherby K. Radioimmunoassay of synthetic progestogens, norethisterone and norgestrel. J Endocrinol. 1974;62(3):605-618. doi: 10.1677/joe.0.0620605 [PubMed 4415456]
Topic 141983 Version 42.0