- For the first time, the FDA has approved an OTC birth control pill.
- Opill is a non-estrogen birth control pill option containing norgestrel, which is similar to progesterone.
- Side effects are often mild and can go away after a few months.
The first-ever over-the-counter birth control accessible without a prescription has been approved by the Food and Drug Administration (FDA). Opill’s manufacturer Perrigo Company has plans to start shipping early next year (2024). Prices have yet to be released and insurance may not cover the medication without a prescription.
Opill is a non-estrogen birth control pill option containing norgestrel, which is similar to progesterone. The FDA
Side effects of Opill noted by the FDA include:
Side effects are generally mild and often resolve on their own. However, if you experience severe or persistent side effects, the FDA recommends seeking medical advice.
“Not everyone who tries hormonal contraception has side effects, but many people do,” says Dr. Raegan McDonald-Mosley, CEO at Power to Decide, a non-profit, non-partisan organization that works to advance sexual and reproductive well-being.
“Side effects are generally mild and usually go away or lessen after the first few months of use as the body adjusts to the new method,” she says.
Dr. G. Thomas Ruiz, OB/GYN lead at MemorialCare Orange Coast Medical Center in Fountain Valley tells Healthline that irregular vaginal bleeding or frequent spotting will resolve as the uterine lining stabilizes (usually within 3 months).
If you’re experiencing cramping with the spotting, he says the class of medications known as NSAIDs, such as aspirin or ibuprofen, will help.
If necessary, Dr. Melissa Bush, OB/GYN and medical director of Obstetrics and Perinatology & Maternal Fetal Medicine at MemorialCare Saddleback Medical Center in Laguna Hills, California tells Healthline there are many effective treatments for troublesome irregular bleeding. “Long-acting progesterone-releasing IUDs are extremely efficacious for contraception and treating irregular bleeding,” she said.
Spotting isn’t unique to Opill, though.
McDonald-Mosley says spotting or unscheduled bleeding is a common side effect in some people when starting Opill or other progestin-only methods such as the injection, implant, hormonal IUD, and progestin-only pills.
Breast tenderness and nausea
“Breast tenderness and nausea are also common side effects with combined hormonal birth control such as the combined pill, the patch, or the ring,” says McDonald-Mosley.
“These side effects usually lessen or go away entirely after the body adjusts to the new method and the hormonal changes,” she says.
Treating birth control side effects
When it comes to reducing side effects from birth control pills, many experts say to wait 3 months and then, if necessary, switch the type of pill or method of contraception and see if that helps.
Your healthcare provider can help in determining which method of contraception may be most suitable and effective.
“There are so many methods of contraception available that if someone is having adverse effects from one, there are a variety of other convenient methods to try,” says Bush.
McDonald-Mosley agrees, stating that there are more than 50 different brands of birth control pills available in the US, and many more types of birth control available beyond the pill.
“While the new over-the-counter pill may be a good place to start, if there are troublesome side effects, seeking out an experienced gynecologist would be of benefit,” says Bush.
There are some cases in which talking to a healthcare provider is still necessary, despite being able to access birth control without a prescription.
Before starting the pill
Bush says people with the following experiences should seek evaluation by a physician prior to starting birth control:
- undiagnosed abnormal uterine bleeding
- repeated vaginal bleeding after sex
- prolonged episodes of bleeding
If you have missed periods
If someone misses two periods, or misses one period and has missed any birth control doses, or suspects they might be pregnant, they should take a pregnancy test, says Bush. If you become pregnant, she says to stop taking Opill.
Heavy bleeding or ongoing spotting
Experts say that if irregular bleeding persists beyond 3 months, it’s time to talk to a healthcare provider about the side effects, potential treatment, or switching to a new method. “If the spotting occurs beyond 3 months or if there is heavy uterine bleeding where you are changing pads, tampons, or a diva cup frequently, consult a physician,” says Ruiz.
Any new onset pelvic pain is also a cause for seeing a healthcare provider, says Ruiz.
If the side effects are very significant or bothersome before the 3-month mark, then McDonald-Mosley says a more urgent evaluation may be necessary.
“Very rarely, people can experience a serious complication from using hormonal birth control such as a blood clot that develops in the leg, a heart attack, or a stroke,” says McDonald-Mosley. “These serious complications are more likely to occur in people who have underlying medical problems,” she adds.
“If someone experiences pain or swelling in one leg, chest pain, trouble breathing or any serious symptoms, they should seek care right away.”
“The FDA’s decision to follow the science and approve the pill over-the-counter at a time when reproductive health and rights are under relentless attack is the first step in what we hope is increased access to reliable and affordable contraception over-the-counter,” McDonald-Mosley tells Healthline.
“Having one birth control pill (a progestin-only pill) available over the counter is an amazing advancement,” she says. “However, there is still a lot of work to be done to ensure that all people have access to the method of their choice from a provider that they are comfortable with and that is attainable without unnecessary barriers.”
Mcdonald-Mosley highlights that roughly 19 million women in need of publicly-funded family planning live in contraceptive deserts, counties where they lack reasonable access to the full range of birth control methods.
“People living in contraceptive deserts are more likely to be people of color and those living in rural communities, all of whom face systemic inequities in access to health care,” she says. “They have to travel farther, arrange more childcare, and take more time off work to get the birth control they need.”
“Affordability is critical to access,” she says. “The FDA ruling will significantly expand access to high-quality contraception, and this must be paired with affordability to ensure access.”
For the first time, an oral contraceptive will be available over the counter. The side effects of medication are expected to be generally mild to moderate and include breast tenderness, spotting, nausea and headaches. In rare cases, it may increase the likelihood of developing a blood clot.