How effective is Opill OTC birth control?
Opill is 91% effective at preventing pregnancy with typical (real world) use and 98% effective when used perfectly (as in clinical studies). As with any birth control method, Opill does not prevent pregnancy all of the time.
Typical use of progestin-only pills like Opill results in 91% effectiveness, meaning 9 in 100 women will become pregnant in one year of using a progestin-only pill, according to ACOG.
- Typical use is not perfect use and includes not taking the pill correctly every day, skipping days between packs, or not always using a back-up method, like a condom, when a pill is missed.
Perfect use results in 98% effectiveness, meaning 2 in 100 women will become pregnant in one year of using Opill.
- Perfect use is usually seen in clinical trials due to the controlled nature of the study, when a pill is taken every day as directed and a back-up method is always used for missed pills. Perfect use is not typical in a real world setting.
When used as directed, Opill is expected to be the most effective form of over-the-counter (OTC) birth control. It is more effective than the condom or spermicide, other over-the-counter options.
In addition, the FDA has stated the product can be used by consumers safely and effectively by following the nonprescription Drug Facts labeling, without any assistance from a healthcare provider.
NOTE: Opill is NOT for use as an emergency contraceptive and will not prevent pregnancy after unprotected sex.
If you have questions about how to take Opill, refer to the Drug Facts Label and consumer information leaflet found with your pack, or ask your doctor or pharmacist.
The over-the-counter (OTC) version of Opill is the same as the prescription birth control product that contains norgestrel.
- In 8 clinical trials conducted in the United States, about 98 out of 100 sexually active women who used Opill over 12 months did not become pregnant in that time, according to the manufacturer’s product label.
- In the FDA advisory committee meetings for Opill, the manufacturer stated that out of 955 participants in one study, only 6 became pregnant while using Opill.
When Opill becomes available, it is expected to be the most effective form of over-the-counter birth control. It is more effective than condoms or spermicides, commonly used over-the-counter options. Opill is expected to be available in the US in March 2024 on pharmacy shelves, grocery and other retail shops and online. It will not require a visit to a healthcare provider.
However, Opill is NOT for use as an emergency contraceptive and will not prevent pregnancy after unprotected sex. Oral contraceptives like Opill do not protect against HIV, AIDS and other sexually transmitted diseases (STDs). Use condoms to prevent STDs.
Opill is an oral contraceptive that is taken by mouth every single day, with no breaks between pill packs. It works best when taken at the same time every day. If you take a pill late, and especially if you miss a pill, you are more likely to get pregnant.
Opill is a progestin-only pill (POP), often referred to as a “mini-pill”. It does not contain estrogen, another hormone also found in combination birth control pills. Do not use Opill if you have or ever had breast cancer.
The FDA has stated the product can be used safely and effectively by the public when following the nonprescription Drug Facts labeling, without assistance from a healthcare provider.
Related Questions
What if I miss a tablet of Opill?
If you take a tablet more than 3 hours late or miss a tablet on 1 or more days, you must use extra contraceptive protection (condoms or another form of barrier contraception) every time you have sex for the next 2 days (48 hours)
You will also need to use extra contraceptive protection every time you have sex for the next 2 days (48 hours) after you start your first pack or if you vomit or have severe diarrhea within 4 hours of taking a tablet.
If you have questions about how to take Opill, refer to the Drug Facts Label and consumer information leaflet found with your pill pack, or ask your doctor or pharmacist.
This is not all the information you need to know about Opill (norgestreol 0.075 mg) for safe and effective use. Review the full Drug Facts Label and Consumer Product Information and discuss this information and any questions you have with your doctor or other health care provider.
References
- Progestin-Only Hormonal Birth Control: Pill and Injection. American College of Obstetricians and Gynecologists (ACOG). Accessed July 29, 2023 at https://www.acog.org/womens-health/faqs/progestin-only-hormonal-birth-control-pill-and-injection
- Opill (0.075mg Oral Norgestrel Tablet) Information. US Food and Drug Administration (FDA). July 13, 2023. Accessed July 13, 2023 at https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/opill-0075mg-oral-norgestrel-tablet-information
- FDA Joint Advisory Committee Votes in Favor of Perrigo's Opill Daily Oral Contraceptive for OTC Use. Press release. May 10, 2023. Accessed July 13, 2023 at https://investor.perrigo.com/2023-05-10-FDA-Joint-Advisory-Committee-Votes-in-Favor-of-Perrigos-Opill-R-Daily-Oral-Contraceptive-for-OTC-Use
- Perrigo Announces U.S. FDA Approval for Opill® OTC Daily Oral Contraceptive. Press release. July 13, 2023. Accessed July 13, 2023 at https://investor.perrigo.com/2023-07-13-Perrigo-Announces-U-S-FDA-Approval-for-Opill-R-OTC-Daily-Oral-Contraceptive
- F.D.A. Approves First U.S. Over-the-Counter Birth Control Pill. New York Times. July 13, 2023. Accessed July 13, 2023 at https://www.nytimes.com/2023/07/13/health/otc-birth-control-pill.html
- FDA Approves First Nonprescription Daily Oral Contraceptive. US Food and Drug Administration (FDA). Accessed July 13, 2023 at https://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive
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Drug information
- Opill Information for Consumers
- Opill prescribing info & package insert (for Health Professionals)
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