Over-the-counter medication · Progestin

levonorgestrel

Also sold as Plan B, Mirena. Iclevia is used to prevent pregnancy in women who are able to have children.

Data updated 2026-05-15

197,074
FDA reportsHeavily reported
37
InteractionsSeveral interactions
$5.97
Generic price (NADAC)

What the data shows

levonorgestrel (Plan B) is an over-the-counter Progestin, more reported than roughly 9 in 10 tracked drugs (197,074 FDA reports), with 37 documented drug interactions.

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.

levonorgestrel (Plan B) is an over-the-counter Progestin. Iclevia is used to prevent pregnancy in women who are able to have children.

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

Verify with FDA → · CMS NADAC pricing →

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 →

NADAC price trail: LEVONORGESTREL 1.5 MG TABLET

Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -12.4% vs prior release.

Effective NADAC / unit vs prior NDCs
September 18, 2024 $6.81/EA - 1
December 18, 2024 $5.97/EA -12.4% 2
Compare with Another Drug → Full Side Effects Report →

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.

The sections below are summarized in plain English from levonorgestrel's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

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.

Side Effects (from patient reports)

Based on 197,074 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for levonorgestrel, by number of reports

reports

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.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

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

05,00010,00015,00020,00025,000 20042007201020132016201920222025 6,514

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

Where levonorgestrel sits

levonorgestrel has more FDA adverse-event reports than 94% 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 levonorgestrel; the line is the median (50th percentile).

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

Reports Mentioning Death

267

0.1% of reports — not proof of cause

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
13 PELVIC PAIN 6,801
14 HEADACHE 6,407
15 PREGNANCY WITH CONTRACEPTIVE DEVICE 5,890
16 MENSTRUATION DELAYED 5,744

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) 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

moderate glecaprevir/pibrentasvir

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.

minor atorvastatin

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.

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 raise the levels of birth control hormones in your blood by changing how your body processes them.

minor topiramate

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.

minor tizanidine

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.

Check all your medications →

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 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 registry lists Headache, Heavy menstrual bleeding, Nausea, Painful menstruation, Acne among the most-reported FAERS reaction terms for levonorgestrel. The compiled record contains 197,074 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does levonorgestrel interact with other medications?
The registry has 37 documented interaction rows for levonorgestrel. Notable source-record pairings include glecaprevir/pibrentasvir, atorvastatin, rosuvastatin. These rows are not a complete medication review.
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.
What pregnancy or breastfeeding source fields are listed for levonorgestrel?
The FDA label for levonorgestrel contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Related Medications in Progestin

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

abiraterone

Zytiga

Abiraterone (Zytiga) is a medicine used with prednisone to treat prostate cancer that has spread.

Compare with levonorgestrel →

anastrozole

Arimidex

Anastrozole is a medicine used to treat breast cancer in women after menopause.

Compare with levonorgestrel →

bazedoxifene/conjugated estrogens

Duavee

Duavee is a combination medicine containing estrogen and a drug that blocks estrogen in some parts of the body.

Compare with levonorgestrel →

cabergoline

Dostinex

Cabergoline is a medicine that helps lower the amount of prolactin in your body.

Compare with levonorgestrel →

clomiphene

Clomid, Serophene

Clomiphene citrate is a medicine that helps women ovulate.

Compare with levonorgestrel →

Compare levonorgestrel vs abiraterone side-by-side →

Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for levonorgestrel: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

Similar FAERS report volume

Nearest drugs by total FAERS reports. This record: 197,074.

4 peers

Similar death-report share

Nearest drugs by FAERS death-report share. This record: 0.14%.

4 peers

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Common Drug Interactions

Dangerous medication combinations and how to protect yourself

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 197,074 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 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