Drospirenone / Ethinyl Estradiol / Levomefolate
Drospirenone / Ethinyl Estradiol / Levomefolate is a combination birth control pill that also raises folate levels and, depending on the product, may treat premenstrual dysphoric disorder (PMDD) and moderate acne.
🧬 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 6 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 ▾
If you smoke and are over 35 years old, do not use this birth control pill. Smoking while taking combination oral contraceptives significantly raises the risk of serious heart and blood vessel problems — including heart attack, stroke, and blood clots — and the risk gets higher the older you are and the more you smoke. Women over 35 who smoke must use a different form of contraception.
📖 Drospirenone / Ethinyl Estradiol / Levomefolate: Patient Information Guide
A plain-language walkthrough of Drospirenone / Ethinyl Estradiol / Levomefolate — 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▾
This ingredient combination is used in several products for birth control and related purposes in females of reproductive potential.
- Prevent pregnancy — all products (Beyaz, Safyral, Tydemy, and generics) are approved oral contraceptives
- Raise folate levels — all products provide folate supplementation to help reduce the risk of neural tube defects if pregnancy occurs while taking the pill or shortly after stopping
- Treat PMDD (premenstrual dysphoric disorder) — Beyaz and the generic drospirenone/ethinyl estradiol/levomefolate calcium combination are approved for this use; Safyral and Tydemy are not approved for PMDD
- Treat moderate acne — Beyaz and the generic combination are approved for moderate acne in females at least 14 years old who also want oral contraception; Safyral and Tydemy are not approved for acne
⚙️How it works▾
The pill prevents pregnancy mainly by stopping ovulation — the release of an egg from the ovary. The synthetic estrogen (ethinyl estradiol) and progestin (drospirenone) work together to suppress the hormonal signals that trigger ovulation each month. Drospirenone also has mild anti-androgenic activity (it partially blocks testosterone-like hormones), which may be relevant for acne, and anti-mineralocorticoid activity (similar to the diuretic spironolactone), meaning it can affect how the body handles sodium and potassium.
The levomefolate calcium component is a ready-to-use form of folate (vitamin B9) that is absorbed directly and builds up in the blood and red blood cells over weeks to months. This elevated folate level is intended to lower the risk of neural tube birth defects if a pregnancy happens while taking the medication or shortly after stopping it.
💊How it's taken▾
Take one tablet by mouth at the same time every day, in the exact order shown on the blister pack — do not skip or rearrange tablets. The pill can be taken with or without food, but taking it after the evening meal or at bedtime may help with nausea. Tablets must be taken consistently; missing pills raises the chance of pregnancy.
- If you miss one hormone pill, take it as soon as you remember — you may take two in one day
- If you miss two or more hormone pills in a row, follow your pack's specific missed-dose instructions and use a backup contraceptive method for at least 7 days
- Do not skip the folate-only (light orange) tablets at the end of the pack — they still provide folate
- Start the next pack the day after finishing the previous one, with no gap between packs
🤒Side effects — in detail▾
The most common side effects reported in clinical trials include:
- Headache or migraine
- Nausea or vomiting
- Irregular bleeding or spotting between periods
- Breast pain or tenderness
- Fatigue
- Irritability or mood changes
- Decreased sex drive
- Weight gain
Serious reactions — including blood clots, stroke, heart attack, liver problems, or sudden vision changes — are rare but require immediate medical attention. Stop the pill and seek care right away if any of these occur.
⚠️Warnings & precautions▾
- Blood clots (VTE): Drospirenone-containing pills may carry a somewhat higher risk of blood clots in the veins (deep vein thrombosis, pulmonary embolism) than pills with some other progestins. Risk is highest in the first year and after restarting. Stop the pill at least 4 weeks before major surgery and don't restart until 2 weeks after; wait at least 4 weeks after giving birth if not breastfeeding.
- High potassium (hyperkalemia): Drospirenone acts like a mild potassium-sparing drug. Do not use if you have kidney, liver, or adrenal disease. If you take other medications that raise potassium, a blood test is needed in your first treatment cycle.
- Smoking over age 35: Combination pills are contraindicated in women over 35 who smoke due to greatly increased risk of heart attack, stroke, and blood clots.
- Blood pressure: This pill can raise blood pressure. Women with uncontrolled high blood pressure should not use it. Monitor blood pressure regularly.
- Liver problems: Stop the pill if yellowing of skin or eyes develops. It is contraindicated in women with liver disease or liver tumors.
- Stroke and arterial events: Use with caution if you have other cardiovascular risk factors. Stop immediately if you experience sudden vision loss, severe headache, or neurological symptoms.
🔀What it interacts with▾
Several drugs and supplements can affect how this pill works or how your body responds to it:
- Enzyme-inducing drugs (phenytoin, carbamazepine, rifampin, some barbiturates, St. John's Wort) — can reduce contraceptive effectiveness; use backup birth control
- Hepatitis C combination drugs containing ombitasvir/paritaprevir/ritonavir ± dasabuvir — must NOT be taken together due to risk of severe liver enzyme elevations
- Potassium-raising drugs (ACE inhibitors, angiotensin II receptor blockers, potassium-sparing diuretics, potassium supplements, heparin, aldosterone antagonists, long-term NSAIDs) — can cause dangerously high potassium when combined with drospirenone; potassium monitoring required
- Strong antifungals and certain HIV/HCV drugs (ketoconazole, itraconazole, some protease inhibitors) — can raise hormone levels and increase potassium risk
- Lamotrigine (seizure/mood medication) — this pill can lower lamotrigine levels, possibly reducing seizure control
- Antifolate drugs (methotrexate, phenytoin, pyrimethamine) — folate in the pill may reduce their effectiveness
- Thyroid hormone replacement — may need dose adjustment because this pill raises thyroid-binding globulin levels
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▾
- Women over 35 who smoke must not use this pill — serious cardiovascular risk
- Do not use with kidney disease, liver disease, or adrenal insufficiency — risk of dangerous potassium elevation
- Do not use with a personal history of blood clots, stroke, heart attack, or certain heart valve or rhythm disorders
- Do not use with uncontrolled high blood pressure or diabetes with blood vessel damage
- Do not use with current or past breast cancer (may be hormone-sensitive)
- Do not use with undiagnosed abnormal uterine (vaginal) bleeding
- Tell your doctor about all medications, especially those that raise potassium — blood tests may be needed in your first month
- Breastfeeding: this pill can reduce milk production; drospirenone passes into breast milk in small amounts; discuss with your doctor
- Not for use before the first period (menarche) or in postmenopausal women
- Acne indication (Beyaz and generics): approved for females at least 14 years old who have already started their periods and want oral contraception
🚑If you take too much▾
No serious harmful effects from overdose have been reported, including accidental ingestion by children. Taking too much may cause nausea or, in females, withdrawal bleeding. Because drospirenone can affect potassium and sodium balance, potassium and sodium levels and signs of metabolic acidosis (chemical imbalance in the blood) should be monitored if overdose occurs.
📡Pharmacodynamics — effects in the body▾
Drospirenone has anti-mineralocorticoid activity comparable to a 25 mg dose of spironolactone, meaning it affects how the kidneys handle sodium and potassium, and it also has anti-androgenic (testosterone-blocking) effects. The estrogen component (ethinyl estradiol) raises levels of sex hormone-binding globulin (SHBG) and reduces free testosterone in the blood. Levomefolate calcium raises plasma and red blood cell folate levels over a period of weeks to months — full steady state in red blood cells takes time because red blood cells live about 120 days.
🔬Pharmacokinetics — how your body processes it▾
Both drospirenone and ethinyl estradiol reach peak blood levels within 1 to 2 hours after taking a tablet. Drospirenone builds up 2 to 3 times in the blood over about 8 days of daily use; ethinyl estradiol reaches steady state during the second half of a treatment cycle. Food can slow absorption and may slightly reduce the amount of ethinyl estradiol absorbed, but the pill can still be taken with or without food. Levomefolate calcium peaks in plasma within about 30 to 90 minutes after a dose and reaches steady state in the blood after 8 to 16 weeks, depending on starting folate levels.
📦How to store it▾
Store at 25 ° C (77 ° F); excursions permitted to 15 ° to 30 ° C (59 ° to 86 ° F) .
📄 Written from Drospirenone / Ethinyl Estradiol / Levomefolate’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 Drospirenone / Ethinyl Estradiol / Levomefolate — the kind of thing our pharmacy team would talk through with you at the counter.
What is this pill actually doing — is it just birth control? ▾
What side effects should I expect when I first start taking it? ▾
I heard this pill can cause blood clots — how worried should I be? ▾
Why does the pharmacist ask if I take ibuprofen or blood pressure medicine? ▾
What happens if I miss a pill? ▾
Can I take this pill if I'm breastfeeding or want to get pregnant soon? ▾
Is Drospirenone / Ethinyl Estradiol / Levomefolate available over the counter? ▾
When was Drospirenone / Ethinyl Estradiol / Levomefolate first available? ▾
Who makes Drospirenone / Ethinyl Estradiol / Levomefolate? ▾
💬 Answers drafted from Drospirenone / Ethinyl Estradiol / Levomefolate’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
📊 Drospirenone / Ethinyl Estradiol / Levomefolate across the U.S. market
How Drospirenone / Ethinyl Estradiol / Levomefolate 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.
Also listed with the FDA, not a patient dose form: Kit (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Drospirenone / Ethinyl Estradiol / Levomefolate is used
A general measure of how commonly Drospirenone / Ethinyl Estradiol / Levomefolate 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 Drospirenone / Ethinyl Estradiol / Levomefolate 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 Drospirenone / Ethinyl Estradiol / Levomefolate prescribed? Of the 1,597 medications we measure, Drospirenone / Ethinyl Estradiol / Levomefolate ranks #917 by Medicaid prescriptions — more than 43% of them.
Utilization by Drospirenone / Ethinyl Estradiol / Levomefolate 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.
Other Drospirenone / Ethinyl Estradiol / Levomefolate products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 4 of 24 listed NDC products with Medicaid activity.
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 Drospirenone / Ethinyl Estradiol / Levomefolate, 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 4 of 24 listed Drospirenone / Ethinyl Estradiol / Levomefolate NDCs with Medicaid activity.
🔍 Compare Drospirenone / Ethinyl Estradiol / Levomefolate products
A representative set of FDA-listed product records for Drospirenone / Ethinyl Estradiol / Levomefolate — 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.)
| Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|
| 💊Kits | ||
| Bayer HealthCare Pharmaceuticals Inc. × 6 listings | NDA | View NDC → |
| Lupin Pharmaceuticals, Inc. × 6 listings | ANDA | View NDC → |
| Sandoz Inc × 3 listings | NDA | View NDC → |
| Sandoz Inc × 3 listings | NDA AUTHORIZED GENERIC | View NDC → |
Showing 18 of 18 products — FDA National Drug Code Directory. For the full list, search the NDC directory →
📈 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 Drospirenone / Ethinyl Estradiol / Levomefolate — 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 Drospirenone / Ethinyl Estradiol / Levomefolate 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 Drospirenone / Ethinyl Estradiol / Levomefolate 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 1013625 1 dose form · 2 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 1013624No current FDA listingClinical drug / strength (SCD) drospirenone 3 MG / ethinyl estradiol 0.02 MG / levomefolate calcium 0.451 MGRxCUI 1013626drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MGRxCUI 1050492
Look up RxCUI 1013625 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 Drospirenone / Ethinyl Estradiol / Levomefolate 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
Drospirenone / Ethinyl Estradiol / Levomefolate 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 6 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. Sandoz Inc 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.