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levonorgestrel

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Brand names: Plan B, Mirena

Progestin OTC

Iclevia is a birth control pill that you take every day to prevent pregnancy. It contains two hormones, levonorgestrel and ethinyl estradiol.

Drug Pricing (NADAC)

Generic Price

$5.97/unit

Generic Available

Yes (51 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Iclevia is used to prevent pregnancy in women who are able to have children.

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 prevents pregnancy by stopping ovulation (the release of an egg from the ovary). It also changes the lining of the uterus, making it harder for a fertilized egg to implant. This medicine also changes the mucus in the cervix, which makes it difficult for sperm to go into the uterus.

How to Take It

Take one Iclevia tablet by mouth every day, at the same time each day, for 91 days. Follow the order of the tablets in the Extended-Cycle Wallet. Start on the first Sunday after your period begins. Use another form of birth control, like condoms, for the first 7 days. After 84 white tablets, take one green tablet daily for 7 days.

Pregnancy & Breastfeeding

Do not use Iclevia if you are pregnant. Iclevia can reduce milk production, so consider another birth control method if you are breastfeeding.

Missed Dose

If you miss a white (active) tablet, take it as soon as you remember. Use a backup method of birth control if you miss more than one tablet.

Storage

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

Side Effects (from patient reports)

Based on 147,360 FDA adverse event reports.

Device coming out
44,868
Device moving out of place
19,856
Irregular periods
14,986
Vaginal bleeding
14,820
Bleeding in the genital area
10,916
Lower abdominal pain
9,174
Stomach pain
8,556
Feeling sick to your stomach
8,442
Pain from a procedure
8,262
Pain
7,480

FDA Adverse Event Report Analysis

Detailed analysis of 197,074 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

197,074

Death-Related Reports

267

Hospitalization Reports

10,709

Top Indication

Contraception

Gender Distribution

Female 194,108 (99%)
Male 1,680 (1%)

Age Distribution

0–17 4,850
18–44 106,973
45–64 10,397
65–74 85
75+ 35

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DEVICE EXPULSION 44,866
2 DEVICE DISLOCATION 19,863
3 MENSTRUATION IRREGULAR 14,989
4 VAGINAL HAEMORRHAGE 14,819
5 GENITAL HAEMORRHAGE 10,916
6 ABDOMINAL PAIN LOWER 9,175
7 ABDOMINAL PAIN 8,552
8 NAUSEA 8,441
9 PROCEDURAL PAIN 8,262
10 PAIN 7,480
11 UTERINE PERFORATION 7,396
12 DRUG INEFFECTIVE 6,967
13 PELVIC PAIN 6,801
14 HEADACHE 6,407
15 PREGNANCY WITH CONTRACEPTIVE DEVICE 5,890

Reactions in Death Reports

DEATH 52
FOETAL EXPOSURE DURING PREGNANCY 21
PREMATURE BABY 16
COMPLETED SUICIDE 15
PAIN 13
SEPSIS 13
ABDOMINAL PAIN 11
ANXIETY 11
DEPRESSION 11
DEHYDRATION 9

Reactions in Hospitalization Reports

UTERINE PERFORATION 3,146
INJURY 3,018
PAIN 2,310
EMOTIONAL DISTRESS 1,857
ANXIETY 1,800
DEVICE DISLOCATION 1,667
ABDOMINAL PAIN 1,651
DEVICE ISSUE 1,610
DEPRESSION 1,492
ABDOMINAL PAIN LOWER 1,130

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. 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: Taking these drugs together can cause your liver enzymes to rise, which may be a sign of liver irritation.

What to do: This combination is not recommended, and your doctor may need to choose a different medication for you.

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 can increase the amount of birth control hormones that stay in your blood by about 20 to 25 percent.

What to do: Your doctor may need to check if your birth control dose is still right for you while you are taking this cholesterol 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 can raise the levels of birth control hormones in your blood by changing how your body processes them.

What to do: Your doctor may need to monitor you for increased side effects from your birth control. Stay alert for any new or unusual symptoms while taking both medications.

Examples Aprepitant, barbiturates, bosentan, carbamazepine, efavirenz, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, rifabutin, rufinamide, topiramate, products containing St.

Mechanism: Topiramate makes your liver work faster to clear birth control hormones from your system. This can make your birth control less effective and increase the risk of pregnancy.

What to do: You should use a backup method of birth control, such as condoms, while taking this medication. Talk to your doctor about whether a different type of contraception is right for you.

Concomitant use with ethinyl estradiol-containing COCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole).

Mechanism: Birth control pills can slow down how your body gets rid of tizanidine. This can cause the medicine to build up in your blood and lead to more side effects.

What to do: Your doctor may need to adjust your tizanidine dose to prevent excessive sleepiness or low blood pressure. Watch closely for increased dizziness or drowsiness.

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Common Questions

What should I do if I experience severe abdominal pain?
Contact your doctor immediately, as it could be a sign of a serious problem.
Can I take Iclevia if I have high blood pressure?
If your high blood pressure is well-controlled, your doctor will monitor your blood pressure closely. If it rises significantly, you should stop taking Iclevia.
Does Iclevia protect against sexually transmitted infections (STIs)?
No, Iclevia does not protect against STIs. You will need to use condoms to protect yourself from STIs.
What if I have a family history of blood clots?
Tell your doctor about your family history of blood clots before starting Iclevia, as it may not be safe for you.
Can I take Iclevia if I am over 40?
Iclevia is generally safe for women over 40 who do not smoke and do not have other risk factors for cardiovascular disease. Talk to your doctor to see if it is right for you.
Will I still get my period while taking Iclevia?
You should have a scheduled period during the 7 days you take the green tablets.
What if I have liver problems?
You should not take Iclevia if you have liver tumors, acute viral hepatitis, or severe cirrhosis.
Can I take Iclevia with other medications?
Some medications can make Iclevia less effective. Tell your doctor about all the medications you take.
What are the signs of a blood clot?
Signs of a blood clot include severe leg pain, chest pain, shortness of breath, sudden vision changes, or weakness on one side of the body.
Is it normal to have irregular bleeding while taking Iclevia?
Irregular bleeding can occur, especially in the first few months. If it persists, talk to your doctor.
What are the common side effects of levonorgestrel?
The most commonly reported side effects of levonorgestrel include Headache, Heavy menstrual bleeding, Nausea, Painful menstruation, Acne. Based on 147,360 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does levonorgestrel interact with other medications?
Yes, levonorgestrel has 37 known drug interactions. Notable interactions include glecaprevir/pibrentasvir, atorvastatin, rosuvastatin. Always inform your doctor about all medications you are taking.
What drug class is levonorgestrel?
levonorgestrel belongs to the Progestin drug class. It is available over the counter (OTC). Iclevia is used to prevent pregnancy in women who are able to have children.
Is levonorgestrel safe during pregnancy?
Do not use Iclevia if you are pregnant. Iclevia can reduce milk production, so consider another birth control method if you are breastfeeding. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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Other drugs grouped near levonorgestrel — same-class peers and common alternatives.

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Medication Guides

Related Health & Safety Data

What the FDA Data Shows for levonorgestrel

The FDA label for levonorgestrel (sold under brand names such as Plan B, Mirena) classifies it as an over-the-counter product in the Progestin class. Iclevia is used to prevent pregnancy in women who are able to have children. 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 147,360 voluntary reports. The database also lists 37 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 $5.97.

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

All federal data sources used on this page