ABSTRACT
In July 2023, the US Food and Drug Administration approved the first over-the-counter (OTC) daily oral contraceptive pill, Opill (norgestrel). The widespread availability of a daily oral contraceptive pill without a prescription is a major advancement in reproductive health and improves access to safe, effective, affordable contraception. This article outlines the types of OTC contraceptives currently available in the United States, with a focus on OTC norgestrel and its implications for increased accessibility to reproductive healthcare.
Opill (norgestrel) is a progestin-only contraceptive pill that became available in US stores and online marketplaces in spring 2024, adding to existing OTC contraceptive options, which include condoms, spermicides, and digital contraceptives.
The only true contraindications to the progestin-only pill include current breast cancer, personal history of breast cancer, or current pregnancy, and most individuals who are unable to use estrogen-containing contraceptives can use norgestrel.
Emergency contraception, such as oral levonorgestrel, is also available OTC and endorsed by the American College of Obstetricians and Gynecologists for contraception without any age restrictions.
Approximately 42% of pregnancies in the United States in 2019 were unintended.1 Unintended pregnancies are associated with delayed or reduced prenatal care, increased rate of preterm births, poorer maternal and infant health outcomes, and higher incidence of maternal depression.2,3
There is a significant unmet need for accessible contraception in the United States, as 1 in 7 sexually active women report that they do not use contraception.4 Challenges to contraceptive access include a required prescription, traveling to clinics, inability to take time off to attend a healthcare appointment, and cost.5,6 Furthermore, since the 2022 Dobbs v Jackson Women’s Health Organization decision, there have been increased disruptions to accessing contraception and high-quality contraceptive care in the United States.7 These obstacles are disproportionately faced by those who are Black, indigenous, or people of color; people with disabilities; lesbian, gay, bisexual, transgender, and queer+ people; and those living in poverty or rural areas.8
Adolescents face different barriers to accessing contraception and reproductive healthcare depending on where they reside.9,10 Minors can consent to contraceptives in 25 states and the District of Columbia, but other states require parental consent.9 Concern about parents discovering contraceptive habits was found to be a major barrier to contraceptive use in adolescents.10
One-third of people seeking combined hormonal contraceptives have difficulty obtaining a prescription, and 19 million people live in “contraceptive deserts,” areas with limited access to healthcare professionals who offer a full range of contraceptive options.11 Hence, individuals may prefer to use OTC contraceptives for pregnancy prevention because they are easier to access than prescription contraceptives.
Increased access to safe and effective OTC contraceptives has the potential to reduce barriers to contraception, decrease health disparities, increase contraceptive use, and reduce unintended pregnancy rates. In July 2023, the first OTC daily oral contraceptive pill, Opill (oral norgestrel), was approved by the US Food and Drug Administration (FDA). Herein, we outline current types of OTC contraceptives available in the United States, with a focus on OTC norgestrel, and highlight the need for healthcare professionals to advocate for increased accessibility to reproductive healthcare.
CURRENTLY AVAILABLE OTC CONTRACEPTIVES
Condoms are widely available, affordable, and commonly used OTC contraceptives, with 8.7% of people in the United States aged 15 to 49 relying on them as their primary method of contraception.12 They protect against pregnancy and sexually transmitted infection but must be used consistently and correctly. Condom use should be encouraged in addition to other types of birth control to protect against sexually transmitted infection (Table 1).13–15
Failure rates and drawbacks of over-the-counter contraceptives
Vaginal spermicides, including gels, foams, and sponges containing nonoxynol-9, immobilize sperm but do not protect against sexually transmitted infection.16 Risks include urinary tract infections and genital irritation and lesions. They have a high failure rate and are not recommended as stand-alone contraception13; see failure rates and drawbacks of OTC contraceptives in Table 1.
The spermicidal contraceptive sponge is a foam disk containing 1 gram of nonoxynol-9 that is activated by moistening with water. It can be inserted up to 24 hours before sex and can be used for multiple acts; it must be left in place for at least 6 hours after sex but no longer than 30 hours total; and it must be discarded after removal.17
Digital contraceptives are applications or wearable devices that use self-tracked menstrual data and algorithms to pinpoint ovulation and identify fertile windows, helping women to plan pregnancy or avoid unintended pregnancy.18 Their effectiveness depends on user compliance and accurate data entry, and further research is warranted to optimize their use and results. Digital contraceptives are often more effective for timing intercourse for conception than for preventing pregnancy. Fertility-awareness contraception provides complete autonomy and is noninvasive, empowering women to personalize contraception.
Emergency contraception, known as the “morning-after pill,” is currently available in 2 oral options: levonorgestrel 1.5 mg (available OTC) and ulipristal acetate, which requires a prescription in the United States and is significantly more effective than levonorgestrel.19 Oral levonorgestrel was approved in the United States in 2006 for emergency contraception within 72 hours of unprotected intercourse but is effective within up to 120 hours, off-label.20,21 It delays or inhibits ovulation and luteal function and is approved for people of all ages.22 Levonorgestrel efficacy declines with time and is reduced in those with higher body mass index.20
While the American College of Obstetricians and Gynecologists affirms that emergency contraception is safe for repeated use,22 it is not the most effective strategy for ongoing pregnancy prevention, as frequent use may lead to menstrual irregularities. Therefore, following repeated emergency contraception use, patients should be counseled regarding effective long-term emergency contraception, such as copper or levonorgestrel intrauterine devices.23,24
OTC pharmaceutical daily contraceptives. Although all the above-mentioned OTC contraceptives provide patients with autonomy and are widely available, they have high failure rates even when used correctly. Daily oral contraceptive pills have been available OTC in more than 100 countries across the world.25 Reproductive health organizations have been advocating for OTC availability in the United States for decades, with significant interest among patients.
In 2016, a reproductive health group completed rigorous clinical trials to study the efficacy and safety of oral norgestrel 0.075 mg and sought FDA approval to change the status from prescription to OTC.26 In studies simulating an OTC environment, consumers reported 85% or higher adherence to taking a progestin-only pill daily for 6 months, and 98% self-selected the progestin-only pill based on the OTC label.27,28 These studies and combined efforts with the pharmaceutical industry eventually led to the FDA’s approval of the first OTC oral contraceptive, a progestin-only pill containing 0.075 mg norgestrel (now marketed as Opill).11,14,21,29–34
OTC NORGESTREL
Before OTC norgestrel became available in stores in March 2024, progestin-only pills were available only by prescription in the United States.21 Progestin-only pills inhibit ovulation to varying degrees, cause cervical mucus thickening to inhibit sperm migration, lower the midcycle peaks of follicle-stimulating hormone and luteinizing hormone, slow egg transit through the fallopian tube, and cause thinning of the endometrium, all of which are unfavorable to fertility.33,34 The failure rate is 2% for perfect use of OTC norgestrel.14
Contraindications and side effects
Progestin-only pills can be used by most patients, unlike estrogen-containing contraceptives, which have several contraindications. According to the US Centers for Disease Control and Prevention Medical Eligibility Criteria for Contraceptive Use,35 combined hormonal contraceptives are contraindicated (category 4, unacceptable health risk) for individuals with a history of venous thromboembolism, migraine with aura, breast cancer, severe liver disease, or uncontrolled hypertension (systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg). Additionally, estrogen-containing contraceptives are not indicated for patients 35 or older who smoke 15 or more cigarettes per day.35
Contraindications to OTC norgestrel include current breast cancer, personal history of breast cancer, current pregnancy, or allergies to any of the drug’s ingredients such as yellow No. 5 (tartrazine).14 However, patients experiencing any abnormal vaginal bleeding, those who have liver tumors or liver disease, or those with a past or current history of cancer should consult a healthcare professional. Certain drug interactions, such as with St. John’s wort or medications used to treat seizures, tuberculosis, human immunodeficiency virus, acquired immunodeficiency syndrome, or pulmonary hypertension, may impact levels of norgestrel and reduce its efficacy, which can lead to unexpected and unintended pregnancy.11
Unlike combined hormonal contraceptives, progestin-only pills are associated with menstrual irregularities, such as amenorrhea, frequent bleeding, or prolonged bleeding.36 Other side effects of OTC norgestrel are typically mild and self-limited and include headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, or bloating.14 However, patients should consult a healthcare professional if side effects are severe or persistent.14
Administration
Because of its short half-life, OTC norgestrel must be taken at the same time every day to be effective, and there are no pill-free days between packs.11,24 Peak serum progestin levels occur about 2 hours after ingestion and return close to baseline by 24 hours.24 Patients are recommended to use backup contraception for 2 days after starting OTC norgestrel. If a dose is missed or taken more than 3 hours late, patients should take 1 tablet as soon as they remember and continue with the next dose at the usual time, even if it means taking 2 tablets in 1 day. Patients should use condoms or another barrier method during intercourse for the next 2 days.14 Fertility returns promptly following discontinuation of OTC norgestrel.
Comparison with prescription progestin-only pills
OTC norgestrel shares similar daily adherence requirements, side effects, and contraindications with other progestin-only contraceptive pills, including norethindrone 0.35 mg and drospirenone 4 mg, which require a prescription.24 However, drospirenone has antiandrogenic and antimineralocorticoid properties that may be preferred for patients with polycystic ovary syndrome, acne, or bloating.37 Additionally, it has a more forgiving 34-hour half-life.38 Drospirenone is contraindicated in patents with kidney disease and adrenal insufficiency and in those who are taking medications that increase potassium levels because it can cause hyperkalemia.38 Further research is necessary to compare the safety and efficacy of OTC norgestrel directly with prescription norethindrone and drospirenone.
PUBLIC HEALTH SIGNIFICANCE OF OTC NORGESTREL
Given its availability in stores and online, OTC norgestrel can improve patient compliance with contraception and address the gap in contraceptive access for people with limited time or access to healthcare, while helping them remain in control of their contraception.11 Patients no longer need to schedule an appointment with a clinician during work hours or even visit a pharmacy to pick up the medication. OTC norgestrel has no specific age restrictions, which is beneficial for adolescents who are sexually active, a group that has historically faced obstacles to access.21 Additionally, there are no gender restrictions for OTC norgestrel; it can be used by transgender men who need contraception. This provides privacy and anonymity and can help reduce healthcare costs.
Concerns
Spanish-speaking patients have been found to have lower comprehension of the Opill OTC label, highlighting the need for availability in different languages.39
Further, it is unclear if the suggested price of Opill ($19.99 for a 1-month supply or $49.99 for a 3-month supply) will hinder its use.21 Research has found that in patients who said they were likely to use OTC birth control pills, 39% said they were willing and able to pay up to $10 per month, and 16% said they would pay more than $20.21 Thus, it is important to advocate for more affordable OTC oral contraceptive options and for wider coverage of OTC contraception by government and private insurance.
CONCLUSION
In summary, OTC norgestrel is generally safe for most people, may be particularly suitable for patients wanting reliable contraception without a prescription, and is appropriate for patients who have contraindications to estrogen-containing contraceptives. Healthcare professionals should disseminate accurate information about available OTC contraceptives, advocate for OTC status for additional hormonal contraceptives, and promote preventive screenings for patients.
DISCLOSURES
The authors report no relevant financial relationships which, in the context of their contributions, could be perceived as a potential conflict of interest.
- Copyright © 2025 The Cleveland Clinic Foundation. All Rights Reserved.
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