Opill (norgestrel) is an OTC progestin-only contraceptive pill used to prevent pregnancy that is available without a prescription. Opill works mainly by thickening your cervical mucus, which makes it difficult for sperm to reach the egg, and it may suppress the release of an egg from your ovary. Opill does not contain estrogen.

Opill will not protect against HIV/AIDS or other sexually transmitted diseases.

Opill starts working 2 days after you start taking it, but you must take it every day at the same time each day for it to continue to be effective. You must take Opill continuously every day without a break between blister packs.

Opill was FDA-approved for OTC (over-the-counter) use on July 13, 2023, and should be available in stores starting in January or February 2024.

Is Opill an OTC medicine?

Yes, Opill is the first daily birth control pill available OTC without a prescription in the United States.

You should not take Opill:

• if you currently have or have ever had breast cancer
• if you are already pregnant or think you may be pregnant
• with another birth control pill, vaginal ring, patch, implant, injection, or an IUD (intra-uterine device)
• as an emergency contraceptive (morning-after pill).  Opill will not prevent pregnancy when used after unprotected sex.

Allergies. Do not take Opill if you are allergic to norgestrel or any of the inactive ingredients. Do not take Opill if you are allergic to FD C Yellow No. 5 (tartrazine). Some people who are allergic to aspirin can also have a tartrazine allergy. Symptoms include hives, facial swelling, asthma (wheezing), shock, skin redness, rash, and blisters.  If you have symptoms of an allergic reaction, stop this medicine and seek medical help immediately. For a full list of ingredients, click here Opill ingredients.

Opill can increase the risk of:

• Ectopic pregnancy, be aware of the possibility of ectopic pregnancy in women who become pregnant or complain of lower abdominal pain while on Opill. Seek medical help if you have symptoms of an ectopic pregnancy, such as sudden or severe persistent pain in your lower belly, mainly on one side.
• Delayed follicular atresia/ovarian cysts, in some cases, they are associated with mild abdominal pain, and rarely they may twist or rupture, requiring surgical intervention. 
• Bleeding pattern alterations, and irregular menstrual patterns are common among women using Opill. Undiagnosed abnormal uterine bleeding should be evaluated before Opill is taken. If uterine bleeding, together with the clinical history, is suggestive of infection, malignancy, pregnancy, or other conditions, rule out these conditions. If periods stop altogether, consider the possibility of pregnancy. 
• Hepatic neoplasia/liver disease, stop Opill if jaundice or acute disturbances of liver function develop. Seek medical help if you have symptoms such as yellowing of your skin or whites of your eyes, especially if you have a fever, tiredness, loss of appetite, or dark-colored urine.

Take 1 tablet at the same time every day

• This tablet works best to prevent pregnancy when taken exactly as directed.
• You can start on any day of your cycle.
• Opill takes 48 hours (2 days) to start working. Use condoms (or another barrier contraceptive method) every time you have sex during the first 2 days of use after you start your first pack of Opill.

Never skip your daily tablet

• To prevent pregnancy, you need to take your tablet every day, even when you bleed or have spotting.
• When you finish a pack, you should start the next one the following day without a break.

If you are more than 3 hours late taking your tablet or miss taking your tablet on 1 or more days

• Take 1 tablet immediately, as soon as you remember.
• Then go back to taking your daily tablet at your usual time.
• Use a condom (or another barrier method) every time you have sex for the next 48 hours (2 days) because the medicine may not be effective.

If you vomit for any reason or have severe diarrhea within 4 hours of taking your daily tablet

• Use a condom (or another barrier method) every time you have sex for the next 48 hours (2 days) because the medicine may not be effective.

When do I need to use extra contraceptive protection?

You need to use extra contraceptive protection (condoms or another form of barrier contraception) every time you have sex for the next 2 days (48 hours)

• After you start your first pack.
• If you take a tablet more than 3 hours late or miss a tablet on 1 or more days.
• If you vomit or have severe diarrhea within 4 hours of taking a tablet. 

Take a pregnancy test or talk to your doctor if: 

• Your period is late after missing taking your tablets in the last month
• If you have not had a period for 2 months and believe you may be pregnant.
• Stop using this medicine, and talk to your doctor if you become pregnant while on the medication.

It is important to continue to see your healthcare provider for your regular healthcare visits.

If you have any of the following medical conditions, it is best to talk to a doctor before taking Opill:

• currently have vaginal bleeding between your periods, and you have not already talked to a doctor about it
• have liver problems
• have or ever had any cancer
• are taking a prescription medicine for seizures, tuberculosis, HIV/AIDS, or pulmonary hypertension
• you are taking a supplement containing St John’s Wort (an herbal ingredient)
• you have taken ulipristal acetate (an emergency contraceptive or morning-after pill) in the past 5 days.

Pregnancy

Talk to your healthcare provider right away if you think that you are pregnant. If you become pregnant while using this medicine, you should stop taking it and talk to your doctor. Occasionally, taking oral contraceptives such as Opill may increase your risk of having an ectopic pregnancy. This means that the pregnancy is outside of the uterus. Symptoms of an ectopic pregnancy are unusual vaginal bleeding or lower stomach area (abdominal) pain. Seek medical help immediately. 

Opill will not delay your ability to get pregnant when you stop taking this medicine.

Breastfeeding

Although small amounts of progestin may pass into breast milk, Opill is considered safe and effective in breastfeeding women. No adverse effects have been found on either breastfeeding performance or infant health.

If you are more than 3 hours later taking your tablet or miss taking your tablet on 1 or more days:

• Take 1 tablet immediately, as soon as you remember.
• Then go back to taking your daily tablet at your usual time.
• Use a condom (or another barrier method) every time you have sex for the next 48 hours (2 days), because the medicine may not be effective.

Symptoms of overdosage may include nausea, vomiting, breast tenderness, dizziness, somnolence (drowsiness/fatigue), and withdrawal bleeding in females. There is no specific antidote, and further treatment of overdose, if necessary, is directed to the symptoms.

Changes in menstrual periods (bleeding) is the most common side effect of Opill.

Less common side effects include:

• headache
• dizziness
• nausea
• increased appetite
• abdominal pain, cramps and bloating
• fatigue
• vaginal discharge
• painful periods
• nervousness
• backache
• breast discomfort
• acne

You should talk to your doctor if:

• You have repeated vaginal bleeding after having sex.
• Your periods start lasting more than 8 days, or they are unusually heavy.
• You start having migraines with aura (headaches that start with vision changes), or if your migraine headaches get worse.

What happens if I miss a dose?

If you are more than 3 hours later taking your tablet or miss taking your tablet on 1 or more days:

• Take 1 tablet immediately, as soon as you remember.
• Then go back to taking your daily tablet at your usual time.
• Use a condom (or another barrier method) every time you have sex for the next 48 hours (2 days), because the medicine may not be effective.

What happens if I overdose?

Symptoms of overdosage may include nausea, vomiting, breast tenderness, dizziness, somnolence (drowsiness/fatigue), and withdrawal bleeding in females. There is no specific antidote, and further treatment of overdose, if necessary, is directed to the symptoms.

What other drugs will affect Opill?

Tell your pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Opill may affect the way other medicines work, and vice versa. 

Especially tell your healthcare provider if you take any of the following medicines:

• phenytoin
• carbamazepine
• barbiturates
• rifampin 
• efavirenz 
• bosentan
• ulipristal acetate
• any herbal preparations containing St. John’s Wort (hypericum perforatum).

Tell your pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Opill may affect the way other medicines work, and vice versa. 

Especially tell your healthcare provider if you take any of the following medicines:

• phenytoin
• carbamazepine
• barbiturates
• rifampin 
• efavirenz 
• bosentan
• ulipristal acetate
• any herbal preparations containing St. John’s Wort (hypericum perforatum).