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 →
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.
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.
This is a plain-language summary of levonorgestrel'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. Iclevia can reduce milk production, so consider another birth control method if you are breastfeeding.
This is a plain-language summary of levonorgestrel'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) tablet, take it as soon as you remember. Use a backup method of birth control if you miss more than one tablet.
This is a plain-language summary of levonorgestrel'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 197,074 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for levonorgestrel, by number of reports
- Device coming out
Device coming out
44,868 reports
- Device moving out of place
Device moving out of place
19,856 reports
- Irregular periods 14,986
Irregular periods
14,986 reports
- Vaginal bleeding 14,820
Vaginal bleeding
14,820 reports
- Bleeding in the genital area 10,916
Bleeding in the genital area
10,916 reports
- Lower abdominal pain 9,174
Lower abdominal pain
9,174 reports
- Stomach pain 8,556
Stomach pain
8,556 reports
- Feeling sick to your stomach 8,442
Feeling sick to your stomach
8,442 reports
- Pain from a procedure 8,262
Pain from a procedure
8,262 reports
- Pain 7,480
Pain
7,480 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.
Reports over time
Adverse-event reports filed for levonorgestrel 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 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.
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
Age Distribution
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
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. 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.
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 severe abdominal pain?
Can I take Iclevia if I have high blood pressure?
Does Iclevia protect against sexually transmitted infections (STIs)?
What if I have a family history of blood clots?
Can I take Iclevia if I am over 40?
Will I still get my period while taking Iclevia?
What if I have liver problems?
Can I take Iclevia with other medications?
What are the signs of a blood clot?
Is it normal to have irregular bleeding while taking Iclevia?
What are the common side effects of levonorgestrel?
Does levonorgestrel interact with other medications?
What drug class is levonorgestrel?
Is levonorgestrel safe during pregnancy?
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 →
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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 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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