Getting birth control pills can be costly and time-consuming: You need to schedule a visit with a doctor, wait for an appointment, get a prescription, have the pharmacy fill it and then repeat the process all over again every few months. Or, at least, that's how it's usually gone — until now. The U.S. Food and Drug Administration (FDA) has just approved the first over-the-counter birth control pill, meaning you can soon pick up a version of the pill in stores without a prescription.[1]
It's called Opill, and it's a progestin-only pill arriving in drugstores, convenience stores, grocery stores and online early next year.
If you're a mom, the potential convenience could save you tons of time — you'll be able to grab birth control while making your weekly grocery run. But what else should you know about over-the-counter birth control? Here's what experts have to say about this new OTC option.
What is Opill?
Opill is a non-prescription oral birth control pill made by Perrigo Company.
"When used as directed, daily oral contraception is safe and is expected to be more effective than currently available non-prescription contraceptive methods in preventing unintended pregnancy," Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, said in a statement. That includes condoms and other barrier methods.
Clinical trial results show that, with perfect use, Opill is 98 percent effective (meaning, on average, only two in 100 women using it will become pregnant in a year). Perfect use is defined as taking the pill every day within the same hour. If it's taken less regularly, the efficacy decreases.
Opill contains the hormone norgestrel, a type of progestin, and does not contain estrogen.[2] Making it available over-the-counter is great news for many OB/GYNs.
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"Having the option of an over-the-counter oral contraceptive pill for women is a win in my eyes," says fertility specialist Asima Ahmad, M.D. "Over-the-counter oral contraceptive pills are available in many countries, and for many women, having this option increases their ability to use oral contraceptive pills."
Is over-the-counter birth control safe?
Yes, over-the-counter birth control is considered safe. The American College of Obstetricians and Gynecologists (ACOG) has "long supported true over-the-counter access to hormonal contraceptives," it said in a statement last year.[3] "Scientific evidence has concluded that over-the-counter access to oral contraception can be accomplished safely and that the overall benefit of increased access to contraception is significant," the group says.
"As the American College of Obstetricians and Gynecologists is for over-the-counter oral contraceptives, I am too," say Mary Jane Minkin, M.D., a clinical professor of obstetrics and gynecology and reproductive sciences at Yale Medical School.
But she notes women should be aware of potential "drawbacks" of progestin-only pills.
"They need to be taken at the same time every day, which is difficult for many women," she says. If you miss a dose of Opill or take it later than three hours from your usual time, you should use back-up birth control like condoms.
Unscheduled bleeding and spotting is the most common side effect of Opill — just like currently available prescription progesterone-only pills. This symptom should improve with time and perfect use.
Opill has some other potential side effects to keep in mind:
- Nausea
- Breast tenderness
- Headaches
Luckily, these symptoms usually remain mild and go away on their own, the FDA says.
It's also worth noting norgestrel isn't new or unstudied; it was approved for use in the U.S. in 1973, but hasn't been available since 2005 when the company decided to stop making it for business reasons.
Can you take the over-the-counter birth control pill if you're breastfeeding?
Yes, you can take Opill if you're breastfeeding, Dr. Minkin says, noting that nursing moms often favor progestin-only birth control methods because they don't impact milk supply.
While you could just pick up Opill and use it if you're nursing, it's not a bad idea to still check in with your doctor first, Dr. Minkin says. There, you can discuss different contraceptive options and which best fit your needs, lifestyle and family planning goals.
FAQ About Opill
How much will the over-counter-birth control pill cost?
There isn't a clear answer right now. Insurance coverage may vary state by state. However, Perrigo states it is committed to making Opill "accessible and affordable to women and people of all ages."
When will over-the-counter birth control become available?
Perrigo has stated it will make Opill available in the U.S. in early 2024.
Does Opill lose effectiveness in women who are overweight or have obesity?
Research has suggested that hormonal contraceptive methods as a whole may work less effectively for women who are overweight or have obesity, although there is no data that clearly states that the pregnancy rate is higher for these women. If you're concerned, talk to your doctor.
Who can't take Opill?
The FDA says a few people should avoid taking Opill, including women who currently have or have had breast cancer; women who are pregnant or think they may be pregnant; and women who are using another birth control pill, vaginal ring, patch, implant, injection or an IUD. Opill should also not be used as an emergency contraceptive.
What drugs or supplements interact with Opill?
The FDA recommends asking your doctor or a pharmacist before you take Opill if you're taking prescription medication for seizures, tuberculosis, HIV/AIDS or pulmonary hypertension; or if you're taking a supplement that contains St John's-wort. Opill may also interact with the morning-after pill.
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