Ethinyl Estradiol / Norelgestromin
Ethinyl estradiol and norelgestromin is a combination hormonal contraceptive skin patch used to prevent pregnancy.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 8 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Two serious warnings appear on this patch's label and they may affect whether you can use it at all.
1. Smoking and serious heart risks: If you smoke and are older than 35, you must not use this patch. Cigarette smoking combined with hormonal contraceptives significantly raises the risk of heart attack, stroke, and other life-threatening cardiovascular events. The more cigarettes you smoke and the older you are, the greater the danger.
2. BMI of 30 or higher: This patch is contraindicated (not allowed) for women with a BMI at or above 30 kg/m². Women in this BMI range who use the patch face a higher risk of venous thromboembolism (blood clots in the veins) compared to women with a lower BMI.
📖 Ethinyl Estradiol / Norelgestromin: Patient Information Guide
A plain-language walkthrough of Ethinyl Estradiol / Norelgestromin — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ethinyl estradiol and norelgestromin is a combination hormonal contraceptive available as a skin patch. All supported products share the same core indication:
- Xulane is indicated for the prevention of pregnancy in women with a BMI below 30 kg/m² for whom a combination hormonal contraceptive is appropriate; it may be less effective in women weighing 198 lbs (90 kg) or more.
- Zafemy is indicated for the prevention of pregnancy in women with a BMI below 30 kg/m² for whom a combination hormonal contraceptive is appropriate; it may be less effective in women weighing 198 lbs (90 kg) or more.
- Gwyn Lo is indicated for the prevention of pregnancy in women with a BMI below 30 kg/m² for whom a combination hormonal contraceptive is appropriate.
- Norelgestromin and ethinyl estradiol transdermal system (generic) is indicated for the prevention of pregnancy in women with a BMI below 30 kg/m²; it may be less effective in women weighing 198 lbs (90 kg) or more.
- All products are contraindicated (not to be used) in women with a BMI of 30 kg/m² or higher.
⚙️How it works▾
The patch delivers two hormones — norelgestromin (a progestin) and ethinyl estradiol (an estrogen) — directly through the skin into the bloodstream, bypassing the digestive system. Together they suppress the hormonal signals from the brain that trigger ovulation, so the ovaries don't release an egg. The hormones also thicken cervical mucus, making it harder for sperm to enter the uterus, and alter the uterine lining to reduce the chance of implantation.
💊How it's taken▾
All patch products use a 28-day (4-week) cycle. Apply a new patch to the upper outer arm, abdomen, buttock, or back once a week for 3 weeks (21 days total), then go patch-free for week 4 — withdrawal bleeding is expected during this week. Always change the patch on the same day each week, wear only one patch at a time, and never cut or damage the patch.
- Start the first patch within the first 24 hours of your period, or use backup contraception for the first 7 days if you start later.
- Never leave more than 7 days between the end of one cycle and the start of the next.
- If you miss or forget a patch change, follow the specific guidance in your product's patient labeling and check with your pharmacist.
🤒Side effects — in detail▾
The most commonly reported side effects with these patches include:
- Breast tenderness, pain, or engorgement
- Nausea or vomiting
- Headache or migraine
- Skin irritation, redness, or rash at the patch site
- Abdominal pain or bloating
- Irregular bleeding or spotting (most common in the first cycle)
- Mood changes, anxiety, or emotional ups and downs
- Acne, dizziness, or weight changes
Seek immediate medical attention for signs of blood clots (leg swelling or pain, chest pain, sudden shortness of breath), stroke (sudden severe headache, vision loss, weakness or numbness), or liver problems (yellowing of the skin or eyes).
⚠️Warnings & precautions▾
- Blood clots (VTE): Using combination hormonal contraceptives increases the risk of dangerous blood clots in the veins or arteries. This patch is contraindicated in women with a BMI ≥ 30 kg/m² due to an even higher clot risk. Stop the patch at least 4 weeks before major surgery and avoid use during long periods of immobility.
- Heart attack and stroke: Smoking, age over 35, high blood pressure, diabetes, and obesity all raise cardiovascular risk with hormonal contraceptives. Women over 35 who smoke must not use this patch.
- Higher estrogen exposure: The total estrogen exposure (AUC) from the patch is about 60% higher than from some oral contraceptives containing the same estrogen dose — this may increase adverse reaction risk, including blood clots.
- Liver disease: Stop the patch immediately if jaundice (yellowing of skin or eyes) develops. Do not use with active liver disease or liver tumors.
- High blood pressure: Monitor blood pressure regularly; discontinue if it rises significantly.
- Depression: Watch carefully in women with a history of depression; discontinue if serious depression returns.
- Headache/migraine: New, severe, or worsening migraines may be a warning sign of a coming stroke — stop the patch and seek evaluation.
🔀What it interacts with▾
Several medications and supplements can interfere with how well this patch works or increase your risk of side effects:
- Enzyme inducers (carbamazepine, phenytoin, rifampin, barbiturates, St. John's wort, topiramate, and others) — lower hormone levels in the blood, reducing contraceptive effectiveness; use backup contraception during use and for 28 days after stopping the inducer.
- Colesevelam (a cholesterol-lowering drug) — significantly reduces estrogen absorption; take at least 4 hours apart.
- Hepatitis C drug combination ombitasvir/paritaprevir/ritonavir (with or without dasabuvir) — can cause dangerous liver enzyme elevations; the patch must be stopped before starting this regimen.
- Certain HIV and HCV antivirals (e.g., nelfinavir, ritonavir, boceprevir, nevirapine) — may lower hormone levels; others (e.g., atazanavir/ritonavir, indinavir) may increase them.
- Lamotrigine (seizure medication) — the patch can lower lamotrigine blood levels, potentially reducing seizure control; dose adjustment may be needed.
- Thyroid or corticosteroid replacement therapy — the patch may increase binding proteins that affect these hormones; replacement doses may need adjustment.
- Atorvastatin, rosuvastatin, grapefruit juice, certain antifungals — may increase estrogen exposure.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use if you smoke and are over age 35 — the risk of serious cardiovascular events is significantly increased.
- Do not use if your BMI is 30 kg/m² or higher — contraindicated due to higher blood clot risk.
- Tell your prescriber if you have a personal or family history of blood clots, stroke, heart attack, or inherited clotting disorders.
- Do not use with liver disease, liver tumors (benign or malignant), or unexplained abnormal uterine bleeding.
- Do not use if you have or have had breast cancer or another hormone-sensitive cancer.
- Tell your doctor if you have uncontrolled high blood pressure, coronary artery disease, atrial fibrillation, or valvular heart disease.
- Tell your doctor if you have diabetes with vascular complications or migraines with aura (visual or neurological warning symptoms before the headache).
- Not recommended while breastfeeding — estrogen can reduce milk production; small amounts of hormones pass into breast milk.
- Stop the patch immediately and tell your doctor if you think you are pregnant.
- Not intended for use before the first menstrual period; not studied in postmenopausal women.
- Women who weigh 198 lbs (90 kg) or more may have reduced protection against pregnancy.
🚑If you take too much▾
If too many patches are worn at once or a patch is accidentally left on too long, symptoms may include nausea, vomiting, and unexpected vaginal bleeding. If you suspect an overdose, remove all patches right away and contact a healthcare provider or poison control for guidance on next steps.
📡Pharmacodynamics — effects in the body▾
During use, the patch suppresses the hormonal signals (FSH and LH) from the brain that control the menstrual cycle, preventing ovulation. After stopping the patch, hormone levels that were suppressed during treatment — including FSH, LH, and estradiol — return to near their pre-treatment baseline levels within about 6 weeks, meaning normal ovarian function typically resumes relatively quickly.
🔬Pharmacokinetics — how your body processes it▾
Because the hormones are delivered through the skin, they bypass first-pass metabolism in the gut and liver — a process that breaks down oral hormones before they reach the bloodstream. Hormone levels reach a steady plateau within about 48 hours of applying the first patch and reach a full steady state within about 2 weeks. After the patch is removed, norelgestromin has a half-life of about 32 hours and ethinyl estradiol about 21 hours, and both drop to very low or undetectable levels in the blood within 3 days. Heat from activities like saunas or whirlpools can increase estrogen absorption, though the progestin component is not significantly affected.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) . Store patches in their protective pouches. store in the refrigerator or freezer.
📄 Written from Ethinyl Estradiol / Norelgestromin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Ethinyl Estradiol / Norelgestromin — the kind of thing our pharmacy team would talk through with you at the counter.
How exactly do I use the patch — do I really have to change it every week? ▾
Where should I put the patch on my body? ▾
What side effects are most common, and which ones mean I need to call a doctor right away? ▾
I heard this patch isn't safe if you smoke — is that true? ▾
Can I use the patch if I'm heavier or have a higher BMI? ▾
Does the patch interact with any common medications or supplements? ▾
Is Ethinyl Estradiol / Norelgestromin available over the counter? ▾
When was Ethinyl Estradiol / Norelgestromin first available? ▾
Who makes Ethinyl Estradiol / Norelgestromin? ▾
💬 Answers drafted from Ethinyl Estradiol / Norelgestromin’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Ethinyl Estradiol / Norelgestromin comes
Ethinyl Estradiol / Norelgestromin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Skin patch
How this form is used
- Xulane, Zafemy, Gwyn Lo, and the generic norelgestromin and ethinyl estradiol transdermal system are all indicated for the prevention of pregnancy in women with a BMI below 30 kg/m²
- Xulane and Zafemy may be less effective in women who weigh 198 lbs (90 kg) or more
- Gwyn Lo is indicated for the prevention of pregnancy in women with a BMI below 30 kg/m² for whom a combination hormonal contraceptive is appropriate
- Xulane, Zafemy, and the generic patch use a 28-day cycle: apply a new patch to the upper outer arm, abdomen, buttock, or back once a week for 3 weeks, then go patch-free for week 4
- Gwyn Lo uses the same 28-day cycle — apply a new patch each week for 3 weeks (21 total days), with week 4 patch-free; withdrawal bleeding is expected during the patch-free week
- Always apply each new patch on the same day of the week (your 'Patch Change Day'), wear only one patch at a time, and never cut or alter the patch
- If applying your first patch after the first 24 hours of your period, use a non-hormonal backup method (such as condoms) for the first 7 days of that first cycle only
📊 Ethinyl Estradiol / Norelgestromin across the U.S. market
How Ethinyl Estradiol / Norelgestromin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Ethinyl Estradiol / Norelgestromin is used
A general measure of how commonly Ethinyl Estradiol / Norelgestromin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Ethinyl Estradiol / Norelgestromin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Ethinyl Estradiol / Norelgestromin prescribed? Of the 1,596 medications we measure, Ethinyl Estradiol / Norelgestromin ranks #243 by Medicaid prescriptions — more than 85% of them.
Utilization by Ethinyl Estradiol / Norelgestromin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System
Summed across the 3 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1534809
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ethinyl Estradiol / Norelgestromin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 16 listed Ethinyl Estradiol / Norelgestromin NDCs with Medicaid activity.
🔍 Compare Ethinyl Estradiol / Norelgestromin products
A representative set of FDA-listed product records for Ethinyl Estradiol / Norelgestromin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Skin patch | ||||
| NORELGESTROMIN 150 mcg/d; ETHINYL ESTRADIOL 35 mcg/d | Transdermal | A-S Medication Solutions | ANDA | View NDC → |
| 35; 150 mcg/d; mcg/d | Transdermal | A-S Medication Solutions | ANDA | View NDC → |
| NORELGESTROMIN 150 mcg/d; ETHINYL ESTRADIOL 35 mcg/d | Transdermal | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| 35; 150 mcg/d; mcg/d | Transdermal | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
| NORELGESTROMIN 150 mcg/d; ETHINYL ESTRADIOL 35 mcg/d | Transdermal | AvKARE | ANDA | View NDC → |
| 35; 150 mcg/d; mcg/d | Transdermal | AvKARE | ANDA | View NDC → |
| NORELGESTROMIN 150 mcg/d; ETHINYL ESTRADIOL 35 mcg/d | Transdermal | Bryant Ranch Prepack | ANDA | View NDC → |
| NORELGESTROMIN 150 mcg/d; ETHINYL ESTRADIOL 35 mcg/d | Transdermal | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| 35; 150 mcg/d; mcg/d | Transdermal | Mylan Pharmaceuticals Inc. | ANDA | View NDC → |
| NORELGESTROMIN 220 mcg/d; ETHINYL ESTRADIOL 20 mcg/d | Transdermal | Viatris Specialty LLC | NDA | View label ↗ |
| NORELGESTROMIN 150 mcg/mg; ETHINYL ESTRADIOL 35 mcg/mg | Transdermal | Zydus Lifesciences Limited | ANDA | View NDC → |
| 35; 150 mcg/mg; mcg/mg | Transdermal | Zydus Lifesciences Limited | ANDA | View NDC → |
| NORELGESTROMIN 150 mcg/mg; ETHINYL ESTRADIOL 35 mcg/mg | Transdermal | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 35; 150 mcg/mg; mcg/mg | Transdermal | Zydus Pharmaceuticals USA Inc. | ANDA | View NDC → |
Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Ethinyl Estradiol / Norelgestromin NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Ethinyl Estradiol / Norelgestromin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Ethinyl Estradiol / Norelgestromin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Ethinyl Estradiol / Norelgestromin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one exact multiple-ingredient concept (MIN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). A product with a different ingredient combination belongs on a different page.
RxCUI 352377 1 dose form · 2 strengths
-
Dose form (SCDF) Transdermal System RxCUI 1806237In current FDA listingsClinical drug / strength (SCD) 168 HR ethinyl estradiol 0.000833 MG/HR / norelgestromin 0.00917 MG/HRRxCUI 2749430168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HRRxCUI 1534809
Look up RxCUI 352377 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Ethinyl Estradiol / Norelgestromin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Ethinyl Estradiol / Norelgestromin belongs to the Progestin class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 8 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Viatris Specialty LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.