ethinyl estradiol/norgestimate
Brand names: Ortho Tri-Cyclen, Sprintec
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.
Common Questions
What should I do if I experience severe headaches while taking Iclevia?
Can I take Iclevia if I have high blood pressure?
What if I have liver problems?
Can I take Iclevia if I am over 35?
What if I have diabetes?
Will Iclevia protect me from sexually transmitted infections (STIs)?
What should I do if I have unexplained vision changes?
Can I take Iclevia after giving birth?
What if I have surgery?
Can I take Iclevia with St. John's Wort?
What are the common side effects of ethinyl estradiol/norgestimate?
Does ethinyl estradiol/norgestimate interact with other medications?
What drug class is ethinyl estradiol/norgestimate?
Is ethinyl estradiol/norgestimate safe during pregnancy?
Related Medications in Combined Oral Contraceptive
Other drugs grouped near ethinyl estradiol/norgestimate — same-class peers and common alternatives.
abiraterone
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anastrozole
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Anastrozole is a medicine used to treat breast cancer in women after menopause.
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bazedoxifene/conjugated estrogens
Duavee
Duavee is a combination medicine containing estrogen and a drug that blocks estrogen in some parts of the body.
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cabergoline
Dostinex
Cabergoline is a medicine that helps lower the amount of prolactin in your body.
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clomiphene
Clomid, Serophene
Clomiphene citrate is a medicine that helps women ovulate.
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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
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages