FAQs
Will consumers know how to use Opill correctly in an OTC setting?
In a behavioral study to evaluate the use of Opill in an OTC-like environment, participants correctly used Opill or followed label directions to use a barrier method during intercourse for the 2 days following a missed pill without assistance from a healthcare provider on 97% of active-use study days.31
Additionally, 95% of study participants were ≥85% adherent to daily Opill dosing or followed label directions to use a barrier method during intercourse for the 2 days following a missed pill.31 The results of this study indicate that the Drug Facts Label guides people to use Opill correctly without involvement of a healthcare provider.
How is Opill dosed?
Opill is dosed once daily at the same 0.075 mg norgestrel dose throughout the cycle, with no placebo pills.3 Opill should be taken within the same 3-hour time frame every day.3 If an individual takes Opill more than 3 hours late or does not take it on 1 or more days, they should use a condom or another barrier method every time they have sex during the next 2 days (48 hours) because it takes 2 days for Opill to start working again.3
When can someone start taking Opill?
Individuals can start taking Opill on any day of the month. If switching from another oral contraceptive, vaginal ring, or patch, they should start taking Opill the day after they stop the other method.* They should use a condom or other barrier method during intercourse for the next 48 hours after Opill initiation, as it takes 2 days for Opill to start working.3
*Read all label information and use as directed.
Who should not use Opill?
Opill should not be used by people who3:
- Have or ever had breast cancer
- Have allergies to this product or any of its ingredients, such as the color additive FD&C yellow No. 5 (tartrazine)
- Are currently using another birth control pill, vaginal ring, patch, implant, injection, or intrauterine device (IUD)
- Are pregnant or think they may be pregnant
- Are male
Individuals should consult with a healthcare provider prior to starting Opill if they3:
- Currently have vaginal bleeding between periods and have not already consulted with a physician
- Have liver tumors or a liver disease
- Have or ever had any cancer
For further information about using progestin-only contraception in these situations, please refer to the US Centers for Disease Control and Prevention (CDC) Medical Eligibility Criteria.
Are there limitations on the use of Opill based on weight?
There are no restrictions for use of Opill based on weight12
Will Opill affect future fertility?
If a person decides they want to become pregnant, they can simply stop taking Opill. Opill will not delay an individual’s ability to get pregnant.3
Can Opill be used by people under 18 years of age?
Yes, Opill can be used by those under 18 years of age with no need for parental consent. The safety and efficacy of Opill tablets have been established in women of reproductive age.2 Major medical organizations (including ACOG,9 AMA,32 SAHM,33 and NASPAG34) support OTC access to oral contraceptives with no age restrictions.
What advice should be given to someone in case of a delayed or missed dose of Opill?
If a person is more than 3 hours late taking their tablet or misses taking their tablet on 1 or more days, they should3:
- Take 1 tablet immediately (as soon as they remember that they missed a dose), then resume taking Opill on their regular schedule
- Use a condom or other barrier method during intercourse for the next 2 days (48 hours) after restarting Opill, as it takes 2 days for Opill to start working again
If a person’s period is late after missing any tablets in the last month, they should take a pregnancy test.3
What drugs may interact with Opill?
The effectiveness of Opill may be reduced by hepatic enzyme–inducing drugs that treat certain disorders, such as3:
- Seizures (barbiturates, carbamazepine, oxcarbazepine, phenytoin, topiramate, primidone)
- Tuberculosis (rifampin, rifabutin)
- Pulmonary hypertension (bosentan)
- HIV/AIDS (efavirenz)
Additionally, St John’s Wort (or any herbal products containing hypericum perforatum) may interfere with Opill’s efficacy.3
During concomitant use of Opill and substances that may affect its efficacy, individuals should use a nonhormonal backup method of contraception (such as a condom).35
If emergency contraception (morning-after pill) has been taken within the last 5 days3:
- Opill should not be used for 5 days after using the emergency contraceptive ulipristal acetate, as it may reduce the effectiveness of both Opill and the emergency contraceptive
- A condom (or other barrier method) should be used during sex until the next period
What if my patient becomes pregnant while taking Opill?
If a patient is pregnant, they should stop taking Opill and seek appropriate medical care.3 Exposure during pregnancy will not cause harm.12
What if my patient experiences migraines while taking Opill?
Opill is appropriate for patients with migraine, including migraine with aura.12 The patient should be referred for appropriate evaluation if they start having migraines with aura or if their migraine headaches get worse.3
What routine healthcare visits should still be scheduled?
No examinations or tests are needed before initiating or continuing Opill.4 The CDC recommends certain routine visits, and the Opill label encourages routine preventive healthcare screenings.3 For specific recommendations, see the US Selected Practice Recommendations for Contraceptive Use, 2016.
Where will consumers be able to purchase Opill?
Opill will be available OTC at most retailers nationwide and online at Opill.com, with subscription options available.
Will Opill also be available as a prescription?
Opill is now approved for OTC use2 by the FDA. Opill does not require a prescription and will be available for purchase over the counter. Opill can be accessed with a prescription and can be covered or reimbursed in the states where a prescription is required for insurance coverage/reimbursement.
Will Opill be eligible for FSA/HSA reimbursement?
Consumers may be able to use their FSA/HSA plans to pay for Opill or to be reimbursed for any out-of-pocket costs. OTC drugs are now generally reimbursable under FSA/HSA plans, subject to the specific details and limitations of individual employers’ plans.