On July 13, 2023, Opill® (norgestrel) tablets, 0.075mg were approved by the U.S. Food and Drug Administration (FDA) as the first over-the-counter (OTC) daily oral contraceptive. Directions are to take one tablet at the same time every day. Opill does not include estrogen; its single progestin ingredient disrupts implantation when taken on a continual basis. Although norgestrel has been FDA-approved to prevent pregnancy for 50 years, it previously has been available only with a prescription. Opill’s marketing is planned for early 2024, but its cost has not yet been released. It will be available in blister cards containing 28 tablets. Product labeling for Opill is here.
At a Glance
- Brand (Generic) Name: Opill® (norgestrel) tablets, 0.075mg
- Manufacturer: The Laboratoire HRA Pharma division of Perrigo
- Date Approved: July 13, 2023
- Indication: to prevent pregnancy
- Dosage Forms Available: Cartons containing one, two, three, or six 28-tablet, blister-packed cards
- Launch Date: Early 2024
- Estimated Annual Cost: Not yet available
- The FDA estimates that as many as three million unplanned pregnancies occur each year in the United States.
- Opill is taken once every day to prevent pregnancy for all women of reproductive age. It is not an emergency contraceptive and it does not prevent sexually transmitted diseases.
- Although the exact way that Opill works as a contraceptive is not completely understood, it changes the consistency of mucus in the cervix and obstructs implantation in the uterus. It also may interfere with ovulation.
- Side effects may include bloating, cramps, dizziness, headaches, heavy periods, and nausea.
- The FDA’s extensive review of research found that the benefits of Opill outweigh its possible adverse effects and that granting it OTC status does not pose any severe risks.
- Labeling for Opill warns against its use by individuals who have breast cancer or who already are pregnant. Those who have irregular periods, liver conditions, or any kind of cancer should consult with a healthcare provider before taking Opill.
- All other daily oral contraceptives currently remain prescription-only in the U.S.