What is The Opill?
  • The Opill is the first oral birth control pill approved by the FDA for over-the-counter use.
    • The Opill is for birth control only, it does not provide protection against sexually transmitted diseases. Barrier methods, such as condoms, must be used to prevent these diseases.
  • The Opill is an oral progestin-only-pill for birth control, commonly referred to as a mini-pill.
    • It has previously been available as a prescription medication sold under brand names such as Elinest or others.
  • It is now available online, and will soon be available in stores.
How do I take the Opill?
  • To take the Opill and ensure it works, you must take one pill within 3 hours of the same time each day.
    • There are no inactive or placebo pills in the Opill package, so this rule applies to all pills.
    • It may be good to set an alarm or reminder due to the importance of a regular dosing schedule.
  • The Opill can be taken with or without food. If the Opill causes nausea or vomiting, taking it with food may help.
What happens if I don’t take it within 3 hours of the same time each day?
  • If a dose is missed by more than 3 hours, take the missed dose as soon as possible and then resume normal dosing times.
    • This means you can take 2 pills in one day (one pill when you remember and one pill at the usual time).
  • If this occurs, the Opill may not work for up to 48 hours. This means you should use backup birth control for at least 48 hours.
How effective is it compared to other oral options?
  • With perfect use, the Opill is greater than 99% effective.
    • However, perfect use means no missed doses and each dose must be within 3 hours of the same time each day.
  • Perfect use is hard to achieve, so researchers also measure how well it works when a normal American uses it. With normal use, the Opill is about 91% effective at preventing pregnancy.
    • This means if 100 people use the Opill as birth control, 9 will become pregnant within one year on average.
    • This decrease in how well it works highlights how important it is to take the pill each day at the same time.
  • With a 91% success rate with normal use, the Opill is roughly as effective as prescription oral birth control options, which includes pills that have both estrogen and progestin.
With normal use, how well does the Opill work compared to non-oral birth control options?
  • The Opill works better than barrier methods such condoms or diaphragms. It also works better than personal measures such as withdrawal or avoiding sex during the most fertile days of a monthly cycle.
  • The Opill is about as effective as other prescription medications (vaginal rings, patches, etc.).
  • The Opill is less effective than medical treatments such as intrauterine-devices (IUDs) or implants.
    • One benefit of the Opill as an oral option is it is quickly reversible compared to medical treatments. Within 1-2 days of your last Opill dose, you will be able to become pregnant again.
What are side effects I should watch out for if I use the Opill?
  • About 50% of patients get some form of irregular bleeding such as spotting, unscheduled or breakthrough bleeding, or the absence of a period.
    • When the Opill was studied, around 12% of patients stopped taking the Opill due to the side effect of irregular bleeds.
  • If you do become pregnant while using the Opill, there is an increased risk of it being outside of the uterus. This can cause serious complications if untreated.
    • When the Opill was studied, up to 10% of pregnancies reported were outside of the uterus. Let your doctor know if you think you may have become pregnant while taking the Opill.
  • Other side effects include things normal of many medications such as headache, nausea or vomiting, upset stomach, or diarrhea.
    • If vomiting or diarrhea occurs within 4 hours of taking the Opill, you will not get the full effect of the Opill. Backup birth control should be used for at least 48 hours.
      • If the Opill causes nausea or vomiting for you, taking it with food may help.
What is the significance of the Opill not having estrogen?
  • Estrogen is included in some oral birth controls to support regular menstruation cycles and avoid irregular bleeding. While this is needed for some patients, it is not needed for others.
  • There are a few groups of patients who should not take the Opill (or any birth control pill with only progestin). These include:
    • People who are pregnant.
    • People who have a history of abnormal bleeding.
    • People with certain kinds of cancer.
      • If you have cancer, check with your doctor or pharmacist to see if Opill is an option for you.
    • People who take medications that reduce how well the Opill works.
      • Make sure your doctor and pharmacist are aware of all your medications to make sure they do not interact with the Opill. This includes over-the-counter medications and supplements.
If estrogen can be good, why isn’t there an over-the-counter option for it?
  • While there are some benefits of a birth control pill having estrogen, there are more serious side effects that some people could experience. These include:
    • Increased risk of blood clots which can lead to events such as heart attack or stroke.
    • Increased risk for specific forms of cancer in patients that are at risk.
  • For these reasons, the FDA still requires a prescription by a doctor to figure out if birth control with estrogen is right for you.

You can speak to your physician or pharmacist to determine if the over-the-counter product is right for you.


Prepared by Derek DeGraaff PharmD Candidate 2024