pharmacopeia
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/api/v1/drug/ethinyl-estradiol

Boxed warning

CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Iclevia, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Iclevia is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 5.1 )

Mechanism of action

Sourced from openFDA

COCs prevent pregnancy primarily by suppressing ovulation.

Estrogen Receptor

Indications

Sourced from openFDA
  • Iclevia TM (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Iclevia is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.

Contraindications

Sourced from openFDA
  • Iclevia is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include females who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ].contraindicated

Dosage & administration

Sourced from openFDA

Take one tablet daily by mouth at the same time every day for 91 days. (2.1) Take tablets in the order directed on the Extended-Cycle Wallet. (2.2) 2.1 How to Start and Take Iclevia Iclevia is dispensed in an Extended-Cycle Wallet [see How Supplied/Storage and Handling (16) ]. Iclevia should be started on a Sunday (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. Table 1: Instructions for Administration of Iclevia Starting Iclevia in females with no current use of hormonal contraception (Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Iclevia active tablets are white (Day 1 to Day 84). Iclevia inactive tablets are green (Day 85 to Day 91). Sunday Start: For each 91-day course, take in the following order: Take the first white tablet (0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, take the tablet on that day. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms or spermicide) for the first 7 days of treatment. Take subsequent white tablets once daily at the same time each day for a total of 84 days. Take one green tablet (inert) daily for the following 7 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 7 days that the green tablets are taken.

Warnings & precautions

Sourced from openFDA

Vascular risks: Stop if a thrombotic or thromboembolic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years. ( 5.1 , 5.5 ) Liver disease: Discontinue if jaundice occurs. ( 5.2 ) Hypertension: If used in women with well-controlled hypertension, monitor blood pressure and stop if blood pressure rises significantly. ( 5.4 ) Gallbladder disease: May cause or worsen gallbladder disease. ( 5.5) Adverse carbohydrate and lipid effects: Monitor glucose in prediabetic and diabetic women taking Iclevia. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. ( 5.7 ) Headache: Evaluate significant change in headaches and discontinue if indicated. ( 5.8 ) Uterine bleeding: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist. ( 5.9 ) 5.1 Thromboembolic Disorders and Other Vascular Conditions Stop Iclevia if an arterial or venous thrombotic/thromboembolic event occurs. Stop Iclevia if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. Discontinue Iclevia during prolonged immobilization. If feasible, stop Iclevia at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.2) ] The most common adverse reactions (≥2%) reported during clinical trials were headache, menorrhagia, nausea, dysmenorrhea, acne, migraine, breast tenderness, weight increased, and depression. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The clinical trial that evaluated the safety and efficacy of levonorgestrel and ethinyl estradiol tablets was a 12-month, randomized, multicenter, open-label study, which enrolled women aged 18 to 40, of whom 456 took at least one dose of levonorgestrel and ethinyl estradiol tablets (345.14 woman-years of exposure) [see Clinical Studies (14) ] .

Use in specific populations

Sourced from openFDA

Pregnancy: Discontinue if pregnancy occurs. ( 8.1 ) Lactation: Advise use of another contraceptive method; Iclevia can decrease milk production. ( 8.2 ) 8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, Iclevia should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. 8.2 Lactation Risk Summary Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding [see Dosage and Administration (2.1)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Iclevia and any potential adverse effects on the breastfed child from Iclevia or the underlying maternal condition.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption No specific investigation of the absolute bioavailability of levonorgestrel and ethinyl estradiol tablets in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability nearly 100%) and is not subject to first-pass metabolism.

Overdosage

Sourced from openFDA

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

Approval history

Sourced from openFDA
  • Sep 5, 2003NDANDA021544Teva Branded Pharm
  • Mar 16, 2006NDANDA021676Bayer Hlthcare
  • Oct 21, 2010NDANDA022501Apil
  • Apr 19, 2013NDANDA204426Apil
  • Jan 9, 2018NDANDA208612Avion Pharms
  • Aug 10, 2018NDANDA209627Mayne Pharma
  • Feb 14, 2020NDANDA204017Agile
  • Jul 22, 2024NDANDA218718Millicent Pr

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Ethinyl Estradiol; Etonogestrel, Ring, .015 mg/1 d; .12 mg/1 d (NDC 0093-7679-02)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
93,208 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Pain15,23916%
  2. 2Pulmonary Embolism13,85115%
  3. 3Injury11,50412%
  4. 4Deep Vein Thrombosis11,34912%
  5. 5Anxiety8,8669.5%
  6. 6Emotional Distress6,6697.2%
  7. 7Nausea6,1116.6%
  8. 8Cholecystitis Chronic5,5916.0%
  9. 9Headache4,7445.1%
  10. 10Cholelithiasis4,3044.6%
  11. 11Dyspnoea4,2144.5%
  12. 12Gallbladder Disorder4,1764.5%
  13. 13Abdominal Pain3,9534.2%
  14. 14Vomiting3,8684.1%
  15. 15Fatigue3,7654.0%

Literature

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Recent PubMed references pinned to Ethinyl Estradiol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 531 ClinicalTrials.gov registrations naming Ethinyl Estradiol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ethinyl Estradiol work?
COCs prevent pregnancy primarily by suppressing ovulation.
What is Ethinyl Estradiol used for?
According to FDA labeling, Ethinyl Estradiol carries indications including: Iclevia TM (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Iclevia is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ethinyl Estradiol?
Ethinyl Estradiol is classified as Estrogens, Natural and semisynthetic estrogens, plain, Estrogen, Estrogen Receptor Agonists, Bone Formation Stimulation, Decreased Embryonic Implantation, Inhibit Ovulation, Vaginal Function Alteration.
What are the brand names for Ethinyl Estradiol?
Ethinyl Estradiol is marketed under brand names including Annovera, EluRyng, Enilloring, Femhrt, Fyavolv, Haloette, Jevantique, Jinteli.
What are the contraindications for Ethinyl Estradiol?
Ethinyl Estradiol labeling lists contraindications including: Iclevia is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include females who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1) ].. Always consult the full prescribing information and a clinician.
Note. Data for ethinyl-estradiol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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