FDA approves the first non-prescription contraceptive

Photo (c) Yulia Reznikov - Getty Images

There are lots of warnings and side effects that users should take into consideration

The U.S. Food and Drug Administration (FDA) has given its approval for a new contraceptive called Opill (norgestrel) tablet to be available without a prescription.

This is the first daily oral contraceptive that can be used in the U.S. without a prescription. Now, people have the option to buy this contraceptive medicine almost anywhere – drug stores, convenience stores, grocery stores, and online.

The biggest question left on the table is how much Opill will cost, but that determination will be left up to the manufacturer. The other X factor is all other forms and doses of oral contraceptives.

According to the FDA’s announcement, those will still require a prescription.

Dr. Patrizia Cavazzoni, the director of the FDA's Center for Drug Evaluation and Research, said, "Today's approval means that millions of people in the United States will have access to a daily oral contraceptive without needing a prescription. When used correctly, daily oral contraception is safe and expected to be more effective than other nonprescription contraceptive methods currently available in preventing unintended pregnancies."

Cavazzoni said that making Opill available without a prescription may make it easier for people to get the contraceptive without having to see a healthcare provider first.

That's quite a paradigm shift given that almost half of the 6.1 million pregnancies in the U.S. each year are unintended. By making Opill accessible without a prescription, the FDA hopes to reduce the number of unintended pregnancies and their negative impacts.

How effective is Opill?

As a contraceptive, the effectiveness of norgestrel, the active ingredient in Opill, was established when it was approved for prescription use in 1973. The FDA says that when used correctly, Opill is safe and effective.

However, Opill must be taken at the same time every day to be effective. Taking medications that interact with Opill can decrease its effectiveness or the effectiveness of the other medication, or both, potentially leading to unintended pregnancies.

Side effects and warnings

The most common side effects of Opill include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating.

The FDA says that Opill should not be used by individuals who have had or currently have breast cancer and that if anyone has any other form of cancer, they should consult a doctor before using Opill. 


  • Opill should not be used in conjunction with other hormonal birth control products such as other oral contraceptives, vaginal rings, contraceptive patches, contraceptive implants, contraceptive injections, or intrauterine devices (IUDs).

  • Using Opill may also cause changes in vaginal bleeding patterns, such as irregular spotting or prolonged bleeding. 

  • Opill is not meant to be used as emergency contraception and does not prevent pregnancy after unprotected sex. 

  • Lastly, it's important to note that oral contraceptives do not protect against sexually transmitted diseases like HIV, AIDS, chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, or syphilis. To prevent sexually transmitted diseases, condoms should be used.

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