What you need to know about Opill, the first over-the-counter birth control pill

Doctors call it one of the safest medications at the pharmacy.

Opill is expected to be available early next year.Uncredited/Associated Press

The Food and Drug Administration on Thursday approved the first daily birth control pill that will be available over the counter. It’s called Opill.

Here’s what you need to know:

How is Opill different from prescription birth control pills?

While many of the prescription pills include both the estrogen and progestin hormones, Opill is a progestin-only pill. Although it is different, it’s not the first such pill out there, according to Dr. Katharine White, a family planning specialist at Boston Medical Center and associate professor of obstetrics and gynecology at the Boston University School of Medicine.

It’s a slightly lower dose than other prescription birth control pills, according to Dr. Erika Werner, chair of obstetrics and gynecology at Tufts Medical Center. Because it’s progestin-only, it’s frequently referred to as the “mini pill.”

How does it work?

Progestin can prevent pregnancy by thickening the mucus lining the cervix, making it more difficult for sperm to penetrate, said Dr. Danielle Roncari, an obstetrician and gynecologist and director of Family Planning at Tufts Medical Center. It can also keep the lining of the uterus quite thin, which makes ovulation more difficult.

But unlike pills with estrogen and progestin, Opill doesn’t prevent ovulation with the same efficacy, Werner said.

Is it safe?

“It is incredibly safe,” White said. “One of the safest over-the-counter medications you can buy at your pharmacy.”

Though it was just approved for over-the-counter use, progestin-only birth control has been in research and in use since the 1970s, Werner said.

“This is not a political decision,” White said. “It is based on science that’s been around for 50 years.”

How effective is it compared to prescription pills?

The efficacy is high, Werner said, but it’s not quite as effective as a prescription birth control pill with both estrogen and progestin, which is more forgiving of missed or delayed doses.

White said that in studies, all birth control pills tend to have similar efficacy rates, around 97 percent if used perfectly and 93 percent if used typically.

A pill used “perfectly,” White said, means it is taken within the same three-hour time frame every day. “Typical” usage means users may sometimes take a pill late, which can risk it not working, or users may not take it at all because they left it at home while traveling or are changing doctors.

It is also much more effective than other over-the-counter options, like condoms and spermicides, White said.

Why do we need an over-the-counter pill?

It offers convenience and broader access.

“Now you don’t have to get to a doctor,” White said. “You just have to get to a pharmacy.”

White said populations who might benefit from an over-the-counter pill are those without access to health care, adolescents who may not feel comfortable speaking to a doctor about birth control, and chronically ill patients whose doctors may not perceive them as needing birth control and so don’t offer it.

It also improves access for patients without insurance.

“It’s brought us up to speed with other countries who have had over-the-counter birth control available for a while,” White said. More than 100 countries offer that birth control, including the United Kingdom and much of Latin American and Asia.

Are there any side effects?

The most common one with progestin-only pills is irregular menstrual bleeding, White said. It often resolves itself within three to six months, though some people may still have spotting afterward.

Does it come with risks of blood clots and strokes like most prescription pills?

The risks commonly associated with prescription pills are caused by the estrogen component, said Roncari. That means a progestin-only pill like Opill will not come with those risks.

Who should not take this pill?

Anyone who has had hormonal irregularities, blood clotting, or a major medical condition such as cancer should consult with their doctor before using this pill, Werner said. However, because it is progestin-only, it is safer for those with metabolic diseases like diabetes.

Does it have any benefits over prescription pills?

“Only if you take it more than a prescription pill,” White said. “The most effective birth control is the one you can get inside your body.”

Overall, Opill is safer for a larger group of people.

“Having another option is something to be excited about,” Roncari said.

Should parents consider letting their teens use Opill instead of getting them a prescription?

This medication is generally well-tolerated and safe to use, but Werner always recommends having a conversation with a doctor before starting any over-the-counter medication.

How much will it cost?

It’s the million-dollar question, White said. Opill’s manufacturer, Perrigo Co., based in Dublin, said it’s committed to affordability, according to White, but it is not yet clear whether the new pill will be covered by insurance.

When will it be available?

It depends on the company and the FDA, but the medication is expected to become available less than a year from now, in early 2024, White said.

An earlier version of this story misstated the first name and one of the affiliations of Dr. Katharine White, a family planning specialist at Boston Medical Center and associate professor of obstetrics and gynecology at the Boston University School of Medicine. The Globe regrets the errors.