FDA Approves Opill, the First Over-the-Counter Birth Control In the U.S.

A woman talks to a pharmacist.
The first OTC daily oral contraceptive will hit shelves next year. Morsa Images/Getty Images
  • The FDA has approved the first over-the-counter (OTC) hormonal contraceptive for use in the U.S.
  • The daily oral contraceptive, Opill, is expected to hit shelves in 2024. There will be no age restrictions.
  • Medical experts and organizations have been pushing for years for an OTC birth control pill.
  • Making birth control medication available without a prescription could prevent millions of unintended pregnancies as more states continue to block abortion access.

The Food and Drug Administration (FDA) has approved Opill, the first over-the-counter oral contraceptive in the United States.

The FDA’s move to make birth control more accessible could help lower the risk of negative maternal and perinatal outcomes. 

Each year, nearly half of the 6.1 million pregnancies in the U.S. are unintended.

“Today’s approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a news release.

“When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy,” Dr. Cavazzoni continued.

The FDA’s approval of Opill also arrives alongside ongoing battles for reproductive rights. 

“In the past two years, we’ve seen an increase in the numbers of states with bans on abortion, often without any real exceptions, even for life or health,” Dr. Sarah W. Prager, a professor in the Department of Obstetrics and Gynecology at the University of Washington School of Medicine, told Healthline. 

“We are already seeing the negative impacts of these bans with increased pregnancy-related morbidity in states where abortion is now illegal. It is more important than ever for people to be able to prevent pregnancy unless or until they desire it, and access to contraception is critical for this.”

What is Opill and when will it be available?

Opill (norgestrel) is a progestin-only daily oral contraceptive pill that will become available in the U.S. without a prescription. Progestin is a synthetic form of the hormone progesterone.

As soon as next year, consumers can purchase Opill at a number of retailers, including: 

  • drug stores
  • convenience stores
  • grocery stores
  • online 

In addition, there will be no age restrictions on sales.

How effective is Opill?

According to the FDA, norgestrel has been approved as an effective contraceptive for prescription use since 1973.

The FDA’s Opill fact sheet states that norgestrel birth control tablets are “highly effective in preventing pregnancy.”

Like many other oral contraceptives, Opill should be taken a the same time every day to ensure its effectiveness.

Early clinical trials with norgestrel tablets have shown an effectiveness rate as high as 98%, according to the FDA, but only when the drug is used “perfectly” and with a backup birth control method, such as condoms, if there is more than a three-hour delay in daily dosage.

Of course, in real life, “perfect use” may be more difficult compared to controlled settings like clinical trials.

In addition, Opill should not be used with other forms of hormonal birth control, such as a contraceptive patch, vaginal ring, or an IUD (intrauterine device), to ensure effectiveness and avoid contraindications.

What are the side effects of Opill?

The FDA notes that common side effects of Opill may include:

  • irregular bleeding
  • headaches
  • dizziness
  • nausea 
  • increased appetite
  • abdominal pain
  • cramps 
  • bloating

Consumers should always talk with their doctor about taking Opill with other medications.

People who have or have had breast cancer should not use Opill, and those living with other forms of cancer should speak with their doctor first.

Why accessible birth control matters

When birth control is available over the counter, people do not have to see a doctor to obtain a contraceptive. 

Making birth control more accessible could help lower the incidence of unintended pregnancies and related negative effects, disproportionately affecting individuals with low socioeconomic status and marginalized racial groups.

When pregnancies are unintended, millions of people cannot obtain the early prenatal care they need. Unintended pregnancies also increase the risk of negative maternal health outcomes, such as: 

  • preterm delivery
  • adverse neonatal development
  • adverse child health 

Medical groups like the American College of Obstetricians and Gynecologists (ACOG) have been lobbying for over-the-counter access to hormonal contraceptives without age restrictions for years.

“Today’s announcement of FDA approval of the OTC sale of progestin-only birth control is a critically important advancement in the accessibility of reproductive health care. ACOG has long supported OTC access to hormonal contraception, and we are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” ACOG officials said in a statement.

In a 2019 opinion letter on access to birth control, the ACOG wrote: 

“Barriers to access are one reason for inconsistent or nonuse of contraception. The requirement for a prescription can be an obstacle for some contraceptive users. Several studies have demonstrated that women are capable of using self-screening tools to determine their eligibility for hormonal contraceptive use.”

Women’s health experts agree. 

“Hormonal birth control, especially progestin-only birth control, has decades of data supporting its overall safety,” Prager said. 

Prager noted research has shown that people have the ability to read labels and determine whether they are a good candidate for over-the-counter birth control, the same way they might be able to determine whether they should use other OTC methods like Tylenol or Ibuprofen.

“I’m thrilled the FDA has approved an over-the-counter birth control pill, and this is an important step forward to provide better access to contraception for people,” Prager said. “This decision is very welcome, if long overdue.”

Takeaway

The FDA has approved Opill, the first-ever over-the-counter birth control medication in the U.S.

The drug is a progestin-only daily oral contraceptive pill that is effective when taken as directed. It is expected to be available to the public in 2024.

Making birth control available without a prescription could improve access for millions of people and prevent unintended pregnancies, which could help reduce the number of adverse maternal health outcomes.

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