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ethinyl estradiol/norgestimate

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Brand names: Ortho Tri-Cyclen, Sprintec

Combined Oral Contraceptive Rx

Iclevia is a birth control pill. It contains two hormones, levonorgestrel and ethinyl estradiol, to prevent pregnancy.

Drug Pricing (NADAC)

Generic Price

$0.11/unit

Generic Available

Yes (1 manufacturer)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Iclevia is used by women who can get pregnant to prevent pregnancy.

Common side effects

Headache, Heavier menstrual bleeding, Nausea

Key warnings

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

How It Works

Iclevia contains two hormones: levonorgestrel and ethinyl estradiol. These hormones prevent ovulation (the release of an egg from the ovary). They also change the lining of the uterus, making it harder for a fertilized egg to implant.

How to Take It

Take one tablet of Iclevia every day for 91 days. Take the tablets in the order shown on the Extended-Cycle Wallet. Start on the first Sunday after your period starts. Use another form of birth control, like condoms, for the first 7 days. After 84 white pills, take one green pill daily for 7 days.

Pregnancy & Breastfeeding

Do not use Iclevia if you are pregnant. Iclevia can reduce milk production while breastfeeding, so another form of birth control is recommended. Talk to your doctor about the best option for you.

Missed Dose

If you miss a white (active) pill, take it as soon as you remember. Use a backup non-hormonal birth control method until you have taken a white tablet daily for 7 consecutive days.

Storage

Store Iclevia at room temperature (68° to 77°F) and protect it from light.

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 more cigarettes. If you are over 35 and smoke, you should not take Iclevia.

Known Drug Interactions

Co-administration of Iclevia and glecaprevir/pibrentasvir is not recommended due to potential for ALT elevations.

Mechanism: Combining these drugs can lead to an increase in liver enzymes, which may indicate liver damage. Because of this risk, the two drugs should not be used together.

What to do: This combination is not recommended. Ask your doctor for a different treatment option to protect your liver.

Substances increasing the systemic exposure of COCs: Co-administration of atorvastatin or rosuvastatin and certain COCs containing ethinyl estradiol (EE) increase AUC values for EE by approximately 20 to 25%.

Mechanism: Atorvastatin increases the amount of birth control hormone in your blood by changing how your body handles the medicine.

What to do: Your healthcare provider may need to monitor you for side effects or adjust your dosages.

Substances increasing the systemic exposure of COCs: Co-administration of atorvastatin or rosuvastatin and certain COCs containing ethinyl estradiol (EE) increase AUC values for EE by approximately 20 to 25%.

Mechanism: Rosuvastatin increases the amount of birth control hormone that stays in your blood. This happens because the statin changes how your body processes the hormone.

What to do: Your doctor may need to monitor you for increased side effects from the birth control. You should report any unusual symptoms to your healthcare provider.

No drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol tablets. ( 7.1 ) 7.1 Effects of Other Drugs on Combined Oral Contraceptives Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs: Table 5 includes substances that demonstrated an important drug interaction with levonorgestrel and ethinyl estradiol tablets. Colesevelam Clinical effect Concomitant use of COCs with colesevelam significantly decreases systemic exposure of ethinyl estradiol [see Clinical Pharmacology (12.3) ] .

Mechanism: Colesevelam can trap the birth control hormones in your gut and stop them from being absorbed into your body. This can make your birth control less effective at preventing pregnancy.

What to do: Take your birth control at least 4 hours before taking colesevelam to make sure it works correctly. Talk to your doctor about the best schedule for your medications.

Table 6: Significant Drug Interaction Information for Drugs Co-Administered With COCs Lamotrigine Clinical effect Concomitant use of COCs with lamotrigine may significantly decrease systemic exposure of lamotrigine due to induction of lamotrigine glucuronidation [See Clinical Pharmacology (12.3) ] . Decreased systemic exposure of lamotrigine may reduce seizure control. Consult the approved product labeling for lamotrigine.

Mechanism: The birth control pill causes your body to break down the seizure medicine lamotrigine much faster than usual. This can lower the amount of medicine in your blood and may lead to more seizures.

What to do: Your doctor may need to increase your dose of lamotrigine to keep your seizures under control. Tell your doctor immediately if you notice any changes in your seizure frequency.

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Common Questions

What should I do if I experience severe headaches while taking Iclevia?
Tell your doctor right away if you have a significant change in headaches. They may want you to stop taking Iclevia.
Can I take Iclevia if I have high blood pressure?
If you have well-controlled high blood pressure, your doctor may monitor your blood pressure while you take Iclevia. If your blood pressure rises significantly, they may have you stop taking it.
What if I have liver problems?
You should not take Iclevia if you have acute hepatitis or severe cirrhosis.
Can I take Iclevia if I am over 35?
If you are over 35 and smoke, you should not take Iclevia.
What if I have diabetes?
If you have diabetes, your doctor may monitor your glucose levels while you are taking Iclevia.
Will Iclevia protect me from sexually transmitted infections (STIs)?
No, Iclevia does not protect against STIs. Use condoms to protect yourself from STIs.
What should I do if I have unexplained vision changes?
Stop taking Iclevia and see a doctor immediately if you have unexplained vision loss, double vision, or bulging eyes.
Can I take Iclevia after giving birth?
If you are not breastfeeding, you can start Iclevia no earlier than 4 weeks after delivery.
What if I have surgery?
If possible, stop Iclevia at least 4 weeks before major surgery and for 2 weeks after.
Can I take Iclevia with St. John's Wort?
No. St. John's Wort may make Iclevia less effective. Talk to your doctor about other birth control options.
What are the common side effects of ethinyl estradiol/norgestimate?
The most commonly reported side effects of ethinyl estradiol/norgestimate include Headache, Heavier menstrual bleeding, Nausea, Painful periods, Acne. Always consult your healthcare provider about potential side effects.
Does ethinyl estradiol/norgestimate interact with other medications?
Yes, ethinyl estradiol/norgestimate has 30 known drug interactions. Notable interactions include glecaprevir/pibrentasvir, atorvastatin, rosuvastatin. Always inform your doctor about all medications you are taking.
What drug class is ethinyl estradiol/norgestimate?
ethinyl estradiol/norgestimate belongs to the Combined Oral Contraceptive drug class. It requires a prescription (Rx). Iclevia is used by women who can get pregnant to prevent pregnancy.
Is ethinyl estradiol/norgestimate safe during pregnancy?
Do not use Iclevia if you are pregnant. Iclevia can reduce milk production while breastfeeding, so another form of birth control is recommended. 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/norgestimate

The FDA label for ethinyl estradiol/norgestimate (sold under brand names such as Ortho Tri-Cyclen, Sprintec) classifies it as a prescription-only medication in the Combined Oral Contraceptive class. Iclevia is used by women who can get pregnant to prevent pregnancy. Official labeling lists 9 commonly reported side effects, including Headache, Heavier menstrual bleeding, Nausea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. The database also lists 30 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.11.

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). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

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: July 2, 2024

All federal data sources used on this page