Prescription medicine
Drospirenone and estetrol Brand names: Nextstellis
Drospirenone and estetrol (Nextstellis) is a prescription medicine with an FDA approval on record since 2021. No generic is listed; pharmacies paid $7.67 per Nextstellis 3-14.2 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the drospirenone and estetrol FDA label on DailyMed (effective May 11, 2023); the NDA 214154 record on Drugs@FDA; every drospirenone and estetrol label on DailyMed.
Highlights of the record
FDA label of May 11, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS.
Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including NEXTSTELLIS, are contraindicated in females who are over 35 years of age and smoke. [See Contraindications (4) and Warnings and Precautions (5.1) ] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Females over 35 years old who smoke should not use NEXTSTELLIS ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
Used for
From the label: indications and usageNEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- April 15, 2021 Nextstellis, Mayne Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 1, 2043 Nextstellis tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $7.67 per tablet Nextstellis 3-14.2 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 274 through July 30, 2026
What is drospirenone and estetrol used for?
From the label: indications and usageNEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy. NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use NEXTSTELLIS may be less effective in females with a BMI ≥ 30 kg/m 2 . In females with BMI ≥ 30 kg/m 2 , decreasing effectiveness may be associated with increasing BMI ( 14 ). Limitations of Use NEXTSTELLIS may be less effective in females with a BMI ≥ 30 kg/m 2 . In females with BMI ≥ 30 kg/m 2 , decreasing effectiveness may be associated with increasing BMI [see Clinical Studies (14) ].
Conditions named in the indications of drospirenone and estetrol's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Nextstellis), Mayne Pharma, effective May 11, 2023 (SPL set c5270073-d083-4109-ae4b-156986175e0a), via openFDA; the full label on DailyMed
What does the patient leaflet for drospirenone and estetrol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about NEXTSTELLIS?Do not use NEXTSTELLIS if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. The risk increases with age and the number of cigarettes you smoke.
From the patient leaflet: How should I store NEXTSTELLIS?Store NEXTSTELLIS at room temperature between 68°F to 77°F (20°C to 25°C). Throw away unused NEXTSTELLIS through a take-back option, if available. You may also visit www.fda.gov/drugdisposal for FDA instructions for throwing away medicine in your household trash. Do not flush NEXTSTELLIS down the toilet. Keep NEXTSTELLIS and all medicines out of the reach of children.
Source: FDA drug label (Nextstellis), Mayne Pharma, effective May 11, 2023 (SPL set c5270073-d083-4109-ae4b-156986175e0a), via openFDA; the full label on DailyMed
Is there a generic for drospirenone and estetrol (Nextstellis)?
No generic drospirenone and estetrol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Nextstellis tablets, the last expiring on October 1, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2043 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for drospirenone and estetrol (Nextstellis)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $7.67 per Nextstellis 3-14.2 mg tablet, up 5% from $7.31 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Nextstellis 3-14.2 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nextstellis 3-14.2 mg tablet | Brand | $7.67 per tablet | $230.03 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the drospirenone and estetrol label say about other medicines?
The drospirenone and estetrol label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lamotrigine | drug interactions | Lamotrigine Clinical Effect Concomitant use of NEXTSTELLIS may decrease lamotrigine exposure [see Clinical Pharmacology (12.3) ], which may reduce efficacy of lamotrigine. |
| Nicotine | warnings and precautions | In addition to cigarettes, use of other nicotine-containing products – including cigars, smokeless tobacco, hookah tobacco, e-cigarettes, and nicotine replacement therapy – may also increase the risk of serious cardiovascular events from CHC use. |
| Ritonavir | contraindications | … [see Warnings and Precautions (5.6) ] Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.7) ] Abnormal uterine bleeding that has an undiagnosed etiology [see Warnings and Precautions … |
| Spironolactone | warnings and precautions | NEXTSTELLIS contains drospirenone, a progestin, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to a 25 mg dose of spironolactone. |
Source: FDA drug label (Nextstellis), Mayne Pharma, effective May 11, 2023 (SPL set c5270073-d083-4109-ae4b-156986175e0a), via openFDA; the full label on DailyMed
What do FAERS reports show for drospirenone and estetrol?
The FDA Adverse Event Reporting System holds 274 reports that list drospirenone and estetrol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 21 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Drospirenone and estetrol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other