estradiol
Brand names: Estrace, Vivelle-Dot
Iclevia is a birth control pill. It contains two hormones, a progestin and an estrogen, that work together to prevent pregnancy.
Drug Pricing (NADAC)
Brand Price
$18.44/unit
Generic Price
$7.76/unit
Generic Savings
58%
Generic Available
Yes (37 manufacturers)
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, Heavy 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 (a progestin) and ethinyl estradiol (an estrogen). These hormones prevent pregnancy by stopping ovulation (the release of an egg from the ovary). They also change the lining of the uterus to prevent a fertilized egg from implanting.
How to Take It
Take one Iclevia tablet every day, at the same time each day. Take the tablets in the order shown on the package. You will take white pills for 84 days, then green pills for 7 days. Start your next pack immediately after finishing the previous one.
Pregnancy & Breastfeeding
Do not use Iclevia if you are pregnant. If you become pregnant while taking Iclevia, stop taking it right away. Iclevia can reduce milk production, so you may want to use a different birth control method while breastfeeding.
Missed Dose
If you miss a white (active) pill, take it as soon as you remember. Then, take your next pill at your regular time. If you miss more than one pill, follow the instructions in the package insert. Use a backup method of birth control (like condoms) for 7 days if you miss pills.
Storage
Store Iclevia at room temperature (68° to 77°F) and protect it from light.
Side Effects (from patient reports)
Based on 45,381 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 83,781 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2000–2025.
Total Reports
83,781
Death-Related Reports
1,484
Hospitalization Reports
11,279
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG INEFFECTIVE | 7,617 |
| 2 | OFF LABEL USE | 5,559 |
| 3 | PRODUCT ADHESION ISSUE | 5,172 |
| 4 | HEADACHE | 5,036 |
| 5 | NAUSEA | 4,754 |
| 6 | FATIGUE | 4,511 |
| 7 | PAIN | 3,480 |
| 8 | HOT FLUSH | 3,279 |
| 9 | DIARRHOEA | 3,056 |
| 10 | DIZZINESS | 2,921 |
| 11 | ARTHRALGIA | 2,816 |
| 12 | RASH | 2,502 |
| 13 | DYSPNOEA | 2,440 |
| 14 | BREAST CANCER FEMALE | 2,439 |
| 15 | PRURITUS | 2,433 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
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. You should not take Iclevia if you are over 35 and smoke.
Known Drug Interactions
Potential to Increase Serum Potassium Concentration There is a potential for an increase in serum potassium concentration in women taking drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets with other drugs that may increase serum potassium concentration [see Warnings And Precautions ( 5.2 ) and And Clinical Pharmacology ( 12.3 )]. 7.3 Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer drospirenone, ethinyl estradiol and levomefolate calcium tablets and levomefolate calcium tablets with HCV drug combinatio...
Mechanism: Drospirenone can cause your body to keep too much potassium, and taking it with other similar drugs can make this effect stronger.
What to do: Your doctor should check your blood potassium levels regularly while you are on these medications.
Co-administration of Iclevia and glecaprevir/pibrentasvir is not recommended due to potential for ALT elevations.
Mechanism: Taking these two drugs at the same time can cause a rise in liver enzymes. This is a sign that the combination might be harmful to your liver.
What to do: This combination is not recommended. Talk to your doctor about using a different treatment to protect your liver health.
Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with Etonogestrel and ethinyl estradiol vaginal ring, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. Note: Etonogestrel and ethinyl estradiol vaginal ring may interfere with the correct placement and position of certain female barrier methods such as a diaphragm or female condom. These methods are not recommended as back-up methods with Etonogestrel and ethinyl estradiol vaginal ...
Mechanism: Certain medications can speed up how the body breaks down birth control hormones. This makes the birth control less effective and increases the risk of pregnancy.
What to do: Use a backup birth control method, like condoms, while taking these drugs. Keep using backup for 28 days after you stop the interacting medication.
Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., verapamil, diltiazem, nifedipine, nicardipine), amiodarone, danazol, ethinyl estradiol, cimetidine, lansoprazole and omeprazole May increase tacrolimus whole blood trough concentrations and increase the risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation) [see Warnings and Precautions ( 5.7 , 5.10 , 5.11 )] .
Mechanism: Estradiol can slow down how your body breaks down tacrolimus, which may increase the amount of medicine in your blood to unsafe levels.
What to do: Your healthcare provider should check your blood levels and watch for any signs of toxicity while you are using both medications.
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 can increase the amount of estrogen that stays in your body.
What to do: Talk to your doctor about this combination, as higher hormone levels may increase your risk of side effects.
Common Questions
What should I do if I experience breakthrough bleeding?
Can I take Iclevia if I have high blood pressure?
Does Iclevia protect against STIs?
Can I take Iclevia if I have a history of blood clots?
What if I have surgery?
Can I take Iclevia if I am breastfeeding?
What if I have liver problems?
Can other medicines affect Iclevia?
What if I have diabetes?
What are the ingredients in Iclevia?
What are the common side effects of estradiol?
Does estradiol interact with other medications?
What drug class is estradiol?
Is there a generic version of estradiol?
Is estradiol safe during pregnancy?
Has estradiol been recalled?
Active Recalls
Failed Content Uniformity Specifications
AvKARE
Failed Impurities/Degradation Specifications.
Zydus Pharmaceuticals (USA) Inc
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Teva Pharmaceuticals USA, Inc
Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Padagis US LLC
Lack of Assurance of Sterility
TMC Acquisition LLC dba Tailor Made Compounding
Failed Stability Specifications; out of specification for shear.
Noven Pharmaceuticals Inc
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Related Medications in Estrogen Hormone
Other drugs grouped near estradiol — same-class peers and common alternatives.
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anastrozole
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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
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clomiphene
Clomid, Serophene
Clomiphene citrate is a medicine that helps women ovulate.
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Medication Guides
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FDA requirements, cost savings, and when the difference matters
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Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for estradiol
The FDA label for estradiol (sold under brand names such as Estrace, Vivelle-Dot) classifies it as a prescription-only medication in the Estrogen Hormone class. Iclevia is used by women who can get pregnant to prevent pregnancy. Official labeling lists 9 commonly reported side effects, including Headache, Heavy menstrual bleeding, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 45,381 voluntary reports. The database also lists 54 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $7.76 versus $18.44 for the brand — a 58% generic savings.
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 (currently 7 recall records on file), 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