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Fixed-dose combination

Drospirenone and Ethinyl estradiol

Also known as drospirenone, ethinyl estradiol
Available on request
Presentations
2
Brands
2
Manufacturers
1
Available from stock
0

Drospirenone and Ethinyl estradiol is a fixed-dose combination medicine indicated by females of reproductive potential to prevent pregnancy. It is available as kits. MedsAcross supplies Drospirenone and Ethinyl estradiol for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

US FDA first approval
11 May 2001
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Dosage forms
Kit
Fixed-dose combination of
Drospirenone, Ethinyl estradiol

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Yasmin ® is indicated for use by females of reproductive potential to prevent pregnancy. Yasmin is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.

Source: US FDA prescribing information

Dosing overview

• Take one tablet daily by mouth at the same time every day. • Tablets must be taken in the order directed on the blister pack. How to Take Yasmin Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. To achieve maximum contraceptive effectiveness, Yasmin must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered. How to Start Yasmin Instruct the patient to begin taking Yasmin either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start). Day 1 Start During the first cycle of Yasmin use, instruct the patient to take one yellow Yasmin daily, beginning on Day 1 of her menstrual cycle.

Source: US FDA prescribing information

Contraindications

Yasmin is contraindicated in females who are known to have or develop the following conditions: • Renal impairment • Adrenal insufficiency • A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: • Smoke, if over age 35 • Have deep vein thrombosis or pulmonary embolism, now or in the past • Have cerebrovascular disease • Have coronary artery disease • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) • Have inherited or acquired hypercoagulopathies • Have uncontrolled hypertension • Have diabetes mellitus with vascular disease • Have…

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (cigarette smoking and serious cardiovascular events): Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. • Vascular risks: Stop Yasmin if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: • Serious cardiovascular events and stroke • Vascular events • Liver disease The most frequent adverse reactions (≥ 2%) are premenstrual syndrome (13.2%), headache /migraine (10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting (4.5%), abdominal pain/tenderness/discomfort (2.3%), mood changes (2.3%).

Source: US FDA prescribing information

Interactions

Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Drospirenone and Ethinyl estradiol, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Yasmin kitDrospirenone and Ethinyl estradiolBayer HealthCare PharmaceuticalsUS FDAAvailable on request
Yaz kitDrospirenone and Ethinyl estradiolBayer HealthCare PharmaceuticalsUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 11 May 2001Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Drospirenone and Ethinyl estradiol available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Drospirenone and Ethinyl estradiol and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Drospirenone and Ethinyl estradiol have?

The catalogue lists 2 brand names for Drospirenone and Ethinyl estradiol, including Yasmin, Yaz.

Is Drospirenone and Ethinyl estradiol approved by the US FDA?

Yes. The US FDA first approved Drospirenone and Ethinyl estradiol on 11 May 2001, according to Drugs@FDA.

Does Drospirenone and Ethinyl estradiol need cold chain shipping?

No listed presentation of Drospirenone and Ethinyl estradiol is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. Yasmin prescribing information (Bayer HealthCare Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 19 May 2023

Request Drospirenone and Ethinyl estradiol for export supply

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