Prescription medication · Combined Oral Contraceptive
ethinyl estradiol/norgestimate
Also sold as Ortho Tri-Cyclen, Sprintec. Iclevia is used by women who can get pregnant to prevent pregnancy.
Data updated 2026-05-15
- 30
- InteractionsSeveral interactions
- $0.11
- Generic price (NADAC)
ethinyl estradiol/norgestimate (Ortho Tri-Cyclen) is a prescription Combined Oral Contraceptive. Iclevia is used by women who can get pregnant to prevent pregnancy.
Iclevia is a birth control pill. It contains two hormones, levonorgestrel and ethinyl estradiol, to prevent pregnancy.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from ethinyl estradiol/norgestimate's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for ethinyl estradiol/norgestimate?
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: July 2, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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