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Prescription medication · Combined Oral Contraceptive

ethinyl estradiol/levonorgestrel

Also sold as Levlen, Triphasil. Amethia is used by women to prevent pregnancy.

Data updated 2026-05-15

94
FDA reports
14
InteractionsSeveral interactions
Rx
Availability

What the data shows

ethinyl estradiol/levonorgestrel (Levlen) is a prescription Combined Oral Contraceptive, with 94 FDA adverse-event reports on file, with 14 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

ethinyl estradiol/levonorgestrel (Levlen) is a prescription Combined Oral Contraceptive. Amethia is used by women to prevent pregnancy.

Amethia is a birth control pill that you take every day to prevent pregnancy. It contains two hormones, estrogen and progestin.

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What it does

Amethia is used by women to prevent pregnancy.

Common side effects

Irregular or heavy uterine bleeding, Weight gain, Acne

Key warnings

Cigarette smoking increases your risk of serious heart problems from birth control pills.

The sections below are summarized in plain English from ethinyl estradiol/levonorgestrel's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Amethia works by preventing ovulation (the release of an egg from the ovary). It also thickens the mucus in the cervix, making it harder for sperm to reach the egg. The hormones in Amethia also change the lining of the uterus.

How to Take It

Take one tablet of Amethia by mouth every day, at the same time each day. Start on the first Sunday after your period begins. Take the white pills for 84 days, then the light blue pills for 7 days. Use a non-hormonal back-up method (like condoms) for the first 7 days.

This is a plain-language summary of ethinyl estradiol/levonorgestrel's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

Pregnancy & Breastfeeding

Amethia should not be used during pregnancy. It is also not recommended if you are breastfeeding, as it can reduce milk production and small amounts of the drug can pass into breast milk.

This is a plain-language summary of ethinyl estradiol/levonorgestrel's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

If you miss a pill, refer to the patient information leaflet for instructions. You may need to use a backup method of birth control.

This is a plain-language summary of ethinyl estradiol/levonorgestrel's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

Store Amethia at room temperature, between 68° to 77°F (20° to 25°C).

Side Effects (from patient reports)

Based on 94 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for ethinyl estradiol/levonorgestrel, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

Cigarette smoking increases your risk of serious heart problems from birth control pills. This risk is higher if you are over 35 and smoke. If you are over 35 and smoke, you should not use Amethia.

Known Drug Interactions

7.2 Increase in Plasma Levels of Estradiol Associated with Co-Administered Drugs Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%.

Mechanism: This cholesterol medicine can increase the amount of estrogen from your birth control that stays in your body. It changes how your body processes the hormone.

What to do: Your doctor may need to adjust your treatment if you have side effects from the higher hormone levels.

7.2 Increase in Plasma Levels of Estradiol Associated with Co-Administered Drugs Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. 7.4 Changes in Plasma Levels of Co-Administered Drugs COCs containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds.

Mechanism: The estrogen in your birth control can slow down how your body processes other estrogen medicines. This can cause the hormone levels to build up in your system.

What to do: Your doctor should check if you need both medicines and may need to adjust your doses.

COCs have been shown to significantly decrease plasma concentrations of lamotrigine likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Mechanism: Birth control pills can make your body get rid of this seizure medicine too quickly. This can lower the amount of medicine in your blood and might cause a seizure.

What to do: Your doctor may need to increase your dose of the seizure medicine.

John's wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors : Significant changes (increase or decrease) in the plasma levels of the estrogen and progestin have been noted in some cases of co-administration of HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.

Mechanism: This medicine can cause the levels of hormones in your birth control to either rise or fall. This might make the birth control less effective at preventing pregnancy.

What to do: You should talk to your doctor about using a backup method of birth control.

Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation.

Mechanism: Acetaminophen stops the body from processing the estrogen in the birth control pill. This leads to higher levels of the hormone in your blood.

What to do: Your doctor may need to monitor you for side effects from higher hormone levels. No immediate change is usually needed for occasional use.

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This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

Common Questions

What should I do if I experience persistent bleeding?
Continue taking Amethia as prescribed, but consult your healthcare provider if the bleeding is persistent or prolonged.
Can Amethia cause weight gain?
Yes, weight gain is a common side effect reported by some women taking Amethia.
What if I start Amethia after giving birth?
If you are not breastfeeding, start Amethia no earlier than 4 to 6 weeks after giving birth. If you haven't had a period yet, get tested for pregnancy first.
Can I take Amethia if I have high blood pressure?
No, you should not take Amethia if you have uncontrolled high blood pressure or high blood pressure with vascular disease.
What if I have a headache while taking Amethia?
If you have a significant change in headaches, talk to your doctor. They may tell you to stop taking Amethia.
Can Amethia affect my liver?
Yes, Amethia can affect your liver. If you develop jaundice (yellowing of the skin or eyes), stop taking Amethia.
What if I am taking medication for Hepatitis C?
You should not take Amethia with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Does Amethia protect against STIs?
No, Amethia does not protect against sexually transmitted infections (STIs). You will need to use condoms to protect yourself from STIs.
What do the white and blue pills contain?
The white pills contain both levonorgestrel and ethinyl estradiol. The light blue pills contain only ethinyl estradiol.
Can other medications affect how Amethia works?
Yes, some drugs and herbal products can make Amethia less effective. Tell your doctor about all medications you take.
What are the common side effects of ethinyl estradiol/levonorgestrel?
The most commonly reported side effects of ethinyl estradiol/levonorgestrel include Irregular or heavy uterine bleeding, Weight gain, Acne, Nausea, Breast tenderness. Based on 94 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does ethinyl estradiol/levonorgestrel interact with other medications?
Yes, ethinyl estradiol/levonorgestrel has 14 known drug interactions. Notable interactions include atorvastatin, estradiol, lamotrigine. Always inform your doctor about all medications you are taking.
What drug class is ethinyl estradiol/levonorgestrel?
ethinyl estradiol/levonorgestrel belongs to the Combined Oral Contraceptive drug class. It requires a prescription (Rx). Amethia is used by women to prevent pregnancy.
Is ethinyl estradiol/levonorgestrel safe during pregnancy?
Amethia should not be used during pregnancy. It is also not recommended if you are breastfeeding, as it can reduce milk production and small amounts of the drug can pass into breast milk. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for ethinyl estradiol/levonorgestrel

The FDA label for ethinyl estradiol/levonorgestrel (sold under brand names such as Levlen, Triphasil) classifies it as a prescription-only medication in the Combined Oral Contraceptive class. Amethia is used by women to prevent pregnancy. Official labeling lists 6 commonly reported side effects, including Irregular or heavy uterine bleeding, Weight gain, Acne.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 94 voluntary reports. The database also lists 14 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: March 1, 2024

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.

All federal data sources used on this page