About Opill®

See what the first daily contraceptive available over the counter (OTC) could mean for your patients.

A contraceptive option that fits your patient’s lifestyle

Opill® is a progestin-only and estrogen-free contraceptive pill. It is suitable for most people, including those who have a contraindication to estrogen and people who are:

  • Smokers
  • Breast-feeding
  • Have a history of migraines**

**If migraines increase in frequency or severity at any time, the patient should be referred for appropriate evaluation.

Simple to use

Opill® is dosed once daily at the same 0.075 mg norgestrel dose.2 For maximum contraceptive effect, Opill® should be taken no later than three hours following the time of the previous day’s dose.

People who take Opill® more than three hours late or miss one or more tablets should:2

  • Take one tablet immediately, then resume Opill® on their regular schedule
  • Use a condom or other barrier method for 48 hours after restarting Opill®
  • Take a pregnancy test or consult their healthcare provider if their period is late after missing any tablets in the last month, or if they suspect they’re pregnant
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Opill® will be available on shelves at pharmacy retailers, online and via subscription.

Opill® efficacy

When used as directed, Opill® is 98% effective.

It will be the most effective form of birth control available without a prescription.1,2

Opill® starts working 48 hours after initation.

It can be initiated any day of the menstrual cycle — no need to wait for menses.2

Opill® does NOT protect individuals from HIV/AIDS or other sexually transmitted diseases. It is NOT an emergency contraceptive and does not prevent pregnancy after unprotected sex.2

How it works

Opill works by:

  • Increasing cervical mucus viscosity to inhibit sperm penetration11
  • Suppressing ovulation some cycles12

Suppresses or disrupts ovulation in some cycles

Increasing cervical mucus viscosity to inhibit sperm penetration

Opill® safety

A well-established safety profile supported by decades of real-world experience

Side effects vary by individual, but Opill® is generally well tolerated. The most frequently reported side effect is irregular bleeding.2

Ectopic Pregnancy

Use of effective contraception decreases risk of pregnancy and risk of ectopic pregnancy overall.13 According to a recent US study, the risk of ectopic pregnancy with any oral contraceptive use is lower than with nonuse.13 Risk of ectopic pregnancy with any oral contraceptive use is low. Opill® is not contraindicated for use in those with a history of ectopic pregnancy.

No examinations or tests are needed before initiating or continuing on Opill®6

For further information, consult the US Medical Eligibility Criteria for Contraceptive Use and the US Selected Practice Recommendations for Contraceptive Use.

Who should not use Opill®?

For further information about using progestin-only contraception in these situations, please refer to the CDC MEC.14

Opill® should not be used by people who2:
  • Have a history of breast cancer
  • Have allergies to this product or any of its ingredients, such as the color additive FD&C yellow No.5 (tartrazine)
  • Are currently using another birth control pill, vaginal ring, patch, implant, injection, or intra-uterine device (IUD)
  • Have a known or suspected pregnancy
  • Are male
Consumers should consult with a healthcare provider prior to use if they2:
  • Currently have vaginal bleeding between periods and have not already consulted with a physician
  • Have liver tumors or liver disease
  • Have or have ever had any cancer
  1. Centers for Disease Control. MMWR. Appendix D: Contraceptive Effectiveness. 2014;63(RR04):47. Accessed April 5, 2023.
  2. Food and Drug Administration. FDA-approved drugs: Opill. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017031. Accessed June 8, 2023.
  3. Grindlay K, Grossman D. Prescription birth control access among US women at risk of unintended pregnancy. J Women’s Health. 2016; 25(3):249-254.
  4. Centers for Disease Control. National Survey of Family Growth 2017-2019. https://www.cdc.gov/nchs/nsfg/nsfg_2017_2019_puf.htm. Accessed July 26, 2023.
  5. Data on file. HRA Pharma. Unpublished analysis of the NSFG data by Pinney Associates 2023.
  6. Curtis KM, Jatlaoui TC, Tepper NK, et al. U.S. Selected Practice Recommendations for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;65(4):1–66.
  7. Biggs MA, Karasek D, Foster DG. Unprotected intercourse among women wanting to avoid pregnancy: attitudes, behaviors, and beliefs. Womens Health Issues. 2012;22(3):e311-e318.
  8. Foster DG, Higgins K, Karasek D, et al. Attitudes towards unprotected intercourse and risk of pregnancy among women seeking abortion. Womens Health Issues. 2012;22(2):e149-e155.
  9. Frederiksen B, Ranji U, Salganicoff A, et al. Women’s sexual and reproductive health services: key findings from the 2020 KFF women’s health survey. Available at: https://www.kff.org/womens-health-policy/issue-brief/womens-sexual-and-reproductive-health-services-key-findings-from-the-2020-kff-womens-health-survey. Accessed May 25, 2023.
  10. Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee- Laboratoire HRA Presentations. Available at: https://www.fda.gov/media/167980/download. Accessed June 5, 2023.
  11. Han L, Creinin MD, Hemon A, et al. Mechanism of action of a 0.075 mg norgestrel progestogen-only pill 2. Effect on cervical mucus and theoretical risk of conception. Contraception. 2022;112:43-47.
  12. Glasier A, Edelman A, Creinin MD, et al. Mechanism of action of norgestrel 0.075 mg a progestin-only pill. I. Effect on ovarian activity. Contraception. 2022;112:37-42.
  13. Raine-Bennett T, Fassett MJ, Chandra M, et al. Ectopic pregnancy prevention: futher evidence of benefits of prescription contraceptives. Contraception. 2022;105:19-25.
  14. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016;63(3):1-103.
  15. Key K, Wollum A, Asetoyer C, et al. Challenges accessing contraceptive care and interest in over-the-counter oral contraceptive pill use among Black, Indigenous, and people of color: an online cross-sectional survey. Contraception. 2023;120:109950.
  16. American College of Obstetricians and Gynecologists. Committee opinion no. 615: Access to contraception. Obstet Gynecol. 2015;125(1):250-255.
  17. American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 788: Over-the-counter access to hormonal contraception. Obstet Gynecol. 2019;134(4):e96-e105.
  18. Power To Decide. Tip sheet: understanding contraceptive deserts. Available at: https://powertodecide.org/what-we-do/information/resource-library/understanding-contraceptive-deserts. Accessed April 26, 2023.
  19. Sonfield A, Hasstedt K, Gold RB. Moving forward: family planning in the era of health reform. New York: Guttmacher Institute. 2014.
  20. Cheng D, Schwarz EB, Douglas E, et al. Unintended pregnancy and associated maternal preconception, prenatal, and postpartum behavior. Contraception. 2009;79(3):194-198.
  21. Dibaba Y, Fantahun M, Hindin MJ. The effects of pregnancy intention on the use of antenatal care services: systemic review and meta-analysis. Reprod Health. 2013;10:50.
  22. Lindberg L, Maddow-Zimet I, Kost K, et al. Pregnancy intentions and maternal and child health: an analysis of longitudinal data in Oklahoma. Matern Child Health J. 2015;19(5):1087-1096.
  23. Mohllajee AP, Curtis KM, Morrow B, et al. Pregnancy intention and its relationship to birth and maternal outcomes. Obstet Gynecol. 2007;109(3):678-686.
  24. Kost K, Lindberg L. Pregnancy intentions, maternal behaviors, and infant health: investigating relationships with new measures and propensity score analysis. Demography. 2015;52(1):83-111. doi:10.1007/s13524-014-0359-9 Maxon P, Miranda ML. Pregnancy intention, demographic differences, and psychosocial health. J Womens Health (Larchmt). 2011;20(8):1215-1223
  25. Maxon P, Miranda ML. Pregnancy intention, demographic differences, and psychosocial health. J Womens Health (Larchmt). 2011;20(8):1215-1223.
  26. Fellenzer JL, Cibula DA. Intendedness of pregnancy and other predictive factors for symptoms of prenatal depression in a population-based study. Matern Child Health J. 2014;18(10):2426-2436.
  27. Abajobir AA, Maravilla JC, Alati R, et al. A systemic review and meta-analysis of the association between unintended pregnancy and perinatal depression. J Affect Dis. 2016;192:56-63.
  28. Grindlay K, Burns B, Grossman D. Prescription requirements and over-the-counter access to oral contraceptives: a global review. Contraception. 2013;88(1):91-96.
  29. Grindlay K, Key K, Zuniga C, et al. Interest in continued use after participation in a study of over-the-counter progestin-only pills in the United States. Womens Health Rep (New Rochelle). 2022;3(1):904-914.
  30. Glasier A, Edelman A, Creinin MD, et al. The effect of deliberate non-adherence to a norgestrel progestin-only pill: a randomized, crossover study. Contraception. 2023;17:1-6.