Prescription medication · Estrogen Hormone

estradiol

Name: estradiol - FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Also sold as Estrace, Vivelle-Dot. Iclevia is used by women who can get pregnant to prevent pregnancy.

Compiled by PlainMeds Editorial, Drug Information Editorial Team

Data updated 2026-05-15

83,781
FDA reportsOften reported: 54
InteractionsMany interactions: 58% less
Generic vs brandBig savings: 17
Recall records

What the data shows

estradiol (Estrace) is a prescription Estrogen Hormone, more reported than most tracked drugs (83,781 FDA reports), whose generic runs roughly half the brand price or less (58% less).

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

estradiol (Estrace) is a prescription Estrogen Hormone. Iclevia is used by women who can get pregnant to prevent pregnancy.

Iclevia is a birth control pill. It contains two hormones, a progestin and an estrogen, that work together to prevent pregnancy.

Verify with FDA → · CMS NADAC pricing →

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 →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

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.

The sections below are summarized in plain English from estradiol'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 (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.

This is a plain-language summary of estradiol's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

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.

This is a plain-language summary of estradiol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

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.

This is a plain-language summary of estradiol's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

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

Side Effects (from patient reports)

Based on 83,781 FDA adverse event reports.

The product did not stick properly

5,172
Headache

5,035
Nausea

4,752
Tiredness

4,511
Pain

3,478
Hot flash

3,279
Diarrhea

3,057
Dizziness

2,921
Joint pain

2,816
Rash

2,502

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Reports over time

Adverse-event reports filed for estradiol each year to the FDA Adverse Event Reporting System (FAERS).

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where estradiol sits

estradiol has more FDA adverse-event reports than 83% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is estradiol; the line is the median (50th percentile).

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

Reports Mentioning Death

1,484

1.8% of reports — not proof of cause

Hospitalization Reports

11,279

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 76,881 (98%)

Male 1,040 (1%)

Age Distribution

0–17 522

18–44 4,583

45–64 25,450

65–74 9,470

75+ 4,818

Most Reported Adverse Reactions (FAERS)

#	Reaction	Reports
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
16	PRODUCT QUALITY ISSUE	2,425
17	INSOMNIA	2,415

Reactions in Death Reports

DEATH 528

COMPLETED SUICIDE 99

PNEUMONIA 86

PAIN 80

DYSPNOEA 76

NAUSEA 73

FATIGUE 69

RENAL FAILURE 63

DIARRHOEA 62

CONDITION AGGRAVATED 59

Reactions in Hospitalization Reports

NAUSEA 1,024

FATIGUE 901

DIARRHOEA 823

PAIN 821

DYSPNOEA 816

HEADACHE 761

FALL 737

VOMITING 706

PNEUMONIA 637

URINARY TRACT INFECTION 599

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

major drospirenone/ethinyl estradiol

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...

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.

moderate glecaprevir/pibrentasvir

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.

moderate etonogestrel

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.

moderate tacrolimus topical

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.

minor rosuvastatin

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.

Check all your medications →

This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

Common Questions

What should I do if I experience breakthrough bleeding?

Irregular bleeding is common, especially during the first few months. If it continues or is heavy, talk to your doctor.

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, you should stop taking Iclevia.

Does Iclevia protect against STIs?

No, Iclevia does not protect against sexually transmitted infections (STIs). Use condoms to protect yourself from STIs.

Can I take Iclevia if I have a history of blood clots?

You should not take Iclevia if you have a history of blood clots.

What if I have surgery?

Stop Iclevia 4 weeks before major surgery and for 2 weeks after. Talk to your doctor.

Can I take Iclevia if I am breastfeeding?

Iclevia can reduce milk production. Talk to your doctor about other birth control options.

What if I have liver problems?

You should not take Iclevia if you have liver tumors, acute viral hepatitis, or severe cirrhosis.

Can other medicines affect Iclevia?

Yes, some medicines can make Iclevia less effective. Tell your doctor about all medicines you take.

What if I have diabetes?

If you have diabetes, your doctor may monitor your glucose levels while you take Iclevia.

What are the ingredients in Iclevia?

Iclevia contains levonorgestrel and ethinyl estradiol, as well as inactive ingredients.

What are the common side effects of estradiol?

The most commonly reported side effects of estradiol include Headache, Heavy menstrual bleeding, Nausea, Painful periods, Acne. Based on 83,781 FDA adverse event reports. Always consult your healthcare provider about potential side effects.

Does estradiol interact with other medications?

Yes, estradiol has 54 known drug interactions. Notable interactions include drospirenone/ethinyl estradiol, glecaprevir/pibrentasvir, etonogestrel. Always inform your doctor about all medications you are taking.

What drug class is estradiol?

estradiol belongs to the Estrogen Hormone drug class. It requires a prescription (Rx). Iclevia is used by women who can get pregnant to prevent pregnancy.

Is there a generic version of estradiol?

Yes, generic estradiol is available from 37 manufacturers. The generic costs $7.76 per unit compared to $18.44 for the brand version, saving approximately 58%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.

Is estradiol safe during pregnancy?

Do not use Iclevia if you are pregnant. If you become pregnant while taking Iclevia, stop taking it right away. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Has estradiol been recalled?

There are 17 recalls associated with estradiol products. Defective Container; packets were found to be either empty or partially full. Check the recalls section below for full details and affected products.

Active Recalls

Class II May 12, 2026

Defective Container; packets were found to be either empty or partially full.

ANI Pharmaceuticals, Inc.

Class II January 26, 2026

Presence of Foreign substance - potential presence of metal particulate matter