The first over-the-counter (OTC) birth control pill is finally on its way. Opill, which was approved by the FDA in July, will be made available for purchase without a prescription in the first quarter of 2024. Up until this point, all birth control pills have only been available by making an appointment with your doctor and getting a prescription. Basically, this is a huge win for birth control accessibility.

Learn more about Opill, how it works, its side effects, and how it differs (slightly) from other birth control methods.

What is Opill? How does it work?

Opill is a progestin-only daily oral contraceptive (form of birth control pill) that will be available for purchase over the counter. No prescription is required. This 0.075mg norgestrel pill prevents pregnancy by thickening cervical mucus to prevent sperm from reaching an egg. In some cases, it can also suppress ovulation.

When do I take it? What if I miss a dose?

Just like other birth control pills, timing is key to efficacy. Opill should be taken orally every day at the same time. Setting an alarm (whether on your phone, computer, etc.) can help you stay on top of your timing.

Missing a pill by more than 3 hours is considered a “missed dose,” which can significantly reduce its effectiveness. If you miss a pill and you’re outside the 3-hour window, you should still take the pill anyway asap and use a backup birth control barrier method, like condoms, for the next two days. If you have sex in the 48 hours following a missed dose, you should also consider using emergency contraception like Julie, a morning-after pill. If vomiting or severe diarrhea occurs within 3 hours of taking the pill, the progestin's absorption may be affected. If this happens, use a backup method until two days after the symptoms subside.

Progesterone vs. Progestin

If you’ve read up on reproductive health and birth control, you might have come across these terms: progesterone and progestin. One is naturally made in the body (progesterone). The other is synthetic (progestin).

Progesterone is a naturally-occurring female hormone produced in the ovaries. It plays a vital role in preparing the uterus lining for pregnancy.

Progestin is a synthetic form of progesterone with a similar function. Progestin is commonly used in several contraceptive medications like the Opill.

The two main types of birth control pills contain varying levels of progestin. Combination birth control pills contain both progestin and estrogen. Progestin-only pills, like the Opill or “mini pill,” contain progestin at a lower dose than combination pills.

Opill effectiveness

Opill's effectiveness sets it apart from other OTC birth control options, like condoms and spermicides, because of its low failure rate.

Typical OTC birth control methods, like condoms, spermicides, and diaphragms, have a 13 to 27%  failure rate.

On the other hand, Opill’s failure rate is expected to be only 7% per year, according to data from HRA Pharma. According to the FDA, out of 100 women who use progestin-only pills over the course of a year,  9 may become pregnant.

Opill’s side effects

All medications, including birth control and the morning-after pill, have potential side effects. The same is true for Opill.

Opill’s potential side effects include:

• irregular bleeding
• headaches
• dizziness
• nausea
• cramps
• sore breasts or breast discomfort

Acne and weight gain are also potential side effects. But like any medication, some people may experience one or a few of these effects with more severity or for a different amount of time. Others may not experience them at all.

And just like other birth control pills, Opill does not protect against STIs.

Is it safe?

Norgestrel, the compound used in Opill, was first approved for prescription use by the FDA in 1973. Many different progestin-only derivatives are currently available by prescription, like Camila, Errin, and Nora-BE.

As a progestin-only birth control option, it presents lower risks of contraindications (reasons not to use the pill). According to the FDA, when HRA Pharma applied to convert norgestrel from a prescription to an OTC product, they had to demonstrate that consumers could use the product safely and effectively by relying on the instructions and information given on the label and without any guidance from a healthcare professional.

HRA’s studies showed that consumers’ comprehension and understanding of Opill’s directions and information was high overall, supporting the notion that the pill can be appropriately used without professional guidance.

Opill is safe and effective, according to HRA. Nonetheless, you should always consult a healthcare professional before starting any kind of medication to ensure it's right for you.

Who makes Opill?

Opill is manufactured by HRA Pharma, known for producing ella, an oral emergency contraception option that uses ulipristal acetate (FYI—ella is only available by prescription in the US. Julie, which contains the hormone levonorgestrel, is available OTC).

In 2022, Perrigo, an American company based in Ireland, acquired HRA Pharma. Perrigo will be the go-to source for Opill’s manufacturing, distribution, and cost.

How much does Opill cost?

Opill’s pricing hasn’t officially been announced and insurance coverage is also up in the air. Current birth control pill costs can range from $20 - $50 per individual pack without insurance. Many people with insurance get their birth control for free or for a reduced rate.

Opill is expected to launch in early 2024, completely changing how convenient and accessible it is for anyone with a uterus to get birth control asap.

Julie is already OTC

Opill hasn’t hit shelves just yet, but if you’ve had unprotected sex and need emergency contraception, Julie is available OTC at CVS, Target, Walmart, and other major stores in all 50 US states. ID, prescription, and parental consent are not required for purchase. Want to learn more about emergency contraception? Check out our article here.

The information above shouldn’t replace the advice of your healthcare professional. For questions about birth control and other women’s health issues, please talk to your healthcare professional.