First OTC Birth Control Pill Hits U.S. Stores

The first over-the-counter birth control pill is now available in some stores in the United States, marking a milestone in expanding the availability of contraception.

Opill (norgestrel) is the first oral contraceptive approved by the U.S. Food and Drug Administration (FDA) for over-the-counter use.

The drug is now available without a prescription in major pharmacies, grocery stores, and on the Opill.com website. The progestin-only pill costs $19.99 for one month and $47.97 for a three-month supply.

OTC use of oral contraceptives has the potential to reduce barriers and increase contraceptive access, according to the American College of Obstetricians and Gynecologists (ACOG).

The organization affirmed that progestin-only oral contraceptive pills are safe and that their over-the-counter availability is appropriate.

How effective is Opill?

Opill must be taken every single day at the same time for perfect-use effectiveness, which can be as high as 98%.

Some studies have suggested that hormonal contraceptives, including norgestrel, might have reduced effectiveness in overweight women.

What are the side effects of Opill?

Side effects of norgestrel are generally mild and include irregular vaginal bleeding, nausea, breast tenderness, and headaches. They often resolve on their own; however, seek medical advice if side effects are severe or persistent.

Opill is generally safe for most individuals but should not be used:

• In people who currently have or have ever had breast cancer.
• In individuals who are pregnant or think they may be pregnant.
• Together with another birth control pill, vaginal ring, patch, implant, injection, or an intra-uterine device (IUD).
• As an emergency contraceptive (morning-after pill).
• In males.

The pill is safe for use during the postpartum period and for those breastfeeding, according to the ACOG advisory.

What is the demand for Opill?

A 2022 KFF survey found that most (77%) American women ages 18-64 favored OTC birth control pills if research showed they are safe and effective. Two in five (39%) said they would likely use such pills approved by the FDA.

Nearly half of the 6.1 million pregnancies in the U.S. each year are unintended and have been linked to adverse outcomes for both mothers and children.

Expanding access to birth control is extremely important in the post-Roe v. Wade era, where 16 states have banned abortion under most circumstances. Moreover, the ongoing Supreme Court threatens to limit or eliminate access to mifepristone, the first medical abortion pill in a two-dose regimen.