What is Femlyv?: A Guide to the First Dissolvable Birth Control Pill

October 7, 2025 •

3 min read

Femlyv gained FDA approval on July 22, 2024, becoming the first-ever orally disintegrating birth control pill. So, what is Femlyv? It is a combination hormonal contraceptive designed for females of reproductive potential to prevent pregnancy, offering a new option for those who may have difficulty swallowing pills.

Quick Summary

Femlyv is a novel, once-daily dissolvable birth control tablet containing norethindrone acetate and ethinyl estradiol. It primarily prevents pregnancy by suppressing ovulation and is the first of its kind.

Key Points

First of Its Kind: Femlyv is the first FDA-approved birth control pill in an orally disintegrating tablet (ODT) form.
Active Ingredients: It's a combination hormonal contraceptive containing norethindrone acetate and ethinyl estradiol.
Primary Use: Femlyv is used to prevent pregnancy in females of reproductive potential.
How it Works: The medication primarily functions by suppressing ovulation, the monthly release of an egg.
Major Warning: Femlyv has a boxed warning for increased risk of serious cardiovascular events in women over 35 who smoke.
Administration: The tablet is taken once daily by dissolving it on the tongue, followed by water.
Target Users: It is a key option for individuals who have difficulty swallowing traditional pills.

A New Era of Contraception

In July 2024, the U.S. Food and Drug Administration (FDA) approved Femlyv, marking a significant development in hormonal contraception. It is the first combination oral contraceptive to be formulated as an orally disintegrating tablet (ODT). This innovation provides a valuable alternative for individuals who have difficulty swallowing traditional pills, expanding access to effective contraception. While the active hormones in Femlyv have been used in birth control pills for decades, the dissolvable delivery method is a novel advancement.

What is Femlyv?

Femlyv is a prescription combination oral contraceptive used to prevent pregnancy. Each pack contains two types of hormones: a progestin (norethindrone acetate) and an estrogen (ethinyl estradiol). As a combined hormonal contraceptive (CHC), it is taken once daily. The medication comes in a 28-day pack, with 24 active hormone-containing tablets and 4 inert reminder tablets.

Active and Inactive Ingredients

Understanding the composition of any medication is crucial.

Active Ingredients: Each of the 24 green, active tablets contains norethindrone acetate and ethinyl estradiol.
Inactive Ingredients: The tablets also contain several inactive ingredients which include mannitol, microcrystalline cellulose, and spearmint flavor to make the orally disintegrating format palatable. The 4 white, inert tablets do not contain any active hormones.

How Does Femlyv Work?

Like other combination birth control pills, Femlyv works primarily by suppressing ovulation, which is the release of an egg from the ovary each month. Without ovulation, fertilization and pregnancy cannot occur. Additionally, Femlyv may cause changes in the cervical mucus, making it more difficult for sperm to reach an egg, and may alter the lining of the uterus.

How to Take Femlyv

Femlyv is designed for ease of use. The tablet should be placed on the tongue where it will dissolve, and then followed with a glass of water. It should be taken once a day, at the same time each day, following the order on the blister pack. The cycle consists of taking one green (active) tablet for 24 consecutive days, followed by one white (inert) tablet for the next four days. It's important not to skip any tablets to maintain contraceptive effectiveness.

Potential Side Effects and Safety Warnings

All medications carry a risk of side effects. For Femlyv, it's critical to be aware of both common reactions and serious warnings.

Common Side Effects

Some of the most common adverse reactions reported in clinical trials include:

Headache
Vaginal yeast infection (candidiasis)
Nausea
Menstrual cramps
Breast tenderness
Bacterial vaginitis
Mood swings
Weight gain

Boxed Warning and Serious Risks

Femlyv has a boxed warning, the FDA's most serious type of warning, regarding cardiovascular risks.

Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, women who are over 35 and smoke should not use Femlyv.

Other serious risks associated with CHCs like Femlyv include:

Blood clots (venous thromboembolism), which can lead to pulmonary embolism or stroke
High blood pressure
Liver tumors (rare)
Gallbladder problems

Comparison: Femlyv vs. Other Contraceptives


Feature	Femlyv (ODT)	Traditional Oral Pill	Hormonal IUD	Contraceptive Patch
Formulation	Orally Disintegrating Tablet	Swallowed Tablet	Intrauterine Device	Transdermal Patch
Mechanism	Suppresses ovulation	Suppresses ovulation	Thickens cervical mucus	Suppresses ovulation
Dosing	Once daily	Once daily	Every 3-8 years	Once weekly (3 weeks on, 1 off)
Key Advantage	Easy to take for those who can't swallow pills	Long history of use, many formulations	Long-acting, low user-effort	Only needs weekly attention

Clinical Trial Insights

Femlyv's effectiveness was established based on studies of tablets with the same active ingredients. In a key clinical trial, the Pearl Index (the number of unintended pregnancies per 100 woman-years of exposure) was 1.82. It's important to note that the efficacy of Femlyv in females with a Body Mass Index (BMI) greater than 35 kg/m² has not been evaluated.

Conclusion

Femlyv represents a meaningful advancement in contraceptive technology, providing an effective birth control method in an orally disintegrating format. Its primary benefit is for individuals who have difficulty swallowing pills, thereby increasing contraceptive options and accessibility. However, like all combined hormonal contraceptives, it carries significant risks, including a boxed warning for cardiovascular events in smokers over 35. A thorough discussion with a healthcare provider is essential to determine if Femlyv is a safe and appropriate choice based on an individual's health profile and lifestyle.

For more detailed information, consult the official FDA package insert.

Frequently Asked Questions

Femlyv is a prescription birth control pill that comes as an orally disintegrating tablet (ODT). It contains two female hormones, norethindrone acetate and ethinyl estradiol, and is used to prevent pregnancy.

The main difference is its formulation. Femlyv is the first birth control pill that dissolves on the tongue, making it an alternative for people who have difficulty swallowing pills. The active hormones it contains have been used in traditional birth control pills for years.

You place one tablet on your tongue once a day, let it dissolve, and then drink a glass of water. It should be taken at the same time each day in the order directed on the 28-day blister pack.

Common side effects include headache, vaginal yeast infection, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, acne, and mood swings.

Femlyv is contraindicated in several groups, most notably women over 35 who smoke. It should also not be used by individuals with a history of deep vein thrombosis or pulmonary embolism, certain types of cancers, uncontrolled high blood pressure, or liver tumors.

No. Like other hormonal contraceptives, Femlyv does not protect against sexually transmitted diseases (STDs) such as HIV, gonorrhea, or chlamydia.

Femlyv was approved by the FDA on July 22, 2024.

If you miss one active green tablet, take it as soon as you remember. If you miss two or more, you should refer to the package insert for detailed instructions and use a backup method of contraception, like condoms, for the next 7 days.