Prescription medicine
Dienogest and estradiol Brand names: Natazia
Dienogest and estradiol (Natazia) is a prescription medicine with an FDA approval on record since 2010. No generic is listed; pharmacies paid $8.46 per Natazia 28 tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the dienogest and estradiol FDA label on DailyMed (effective June 26, 2024, Bayer HealthCare Pharmaceuticals Inc.); the NDA 22252 record on Drugs@FDA; every dienogest and estradiol label on DailyMed.
Highlights of the record
FDA label of June 26, 2024; 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 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. [See Contraindications ( 4 ).] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning.
Women over 35 years old who smoke should not use Natazia. ( 4 )
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
Used for
From the label: indications and usageNatazia is a combination of dienogest, a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- May 6, 2010 Natazia, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 30, 2028 Natazia tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $8.46 per tablet Natazia 28 tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 316 through July 30, 2026
What is dienogest and estradiol used for?
From the label: indications and usageNatazia is a combination of dienogest, a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of >30 kg/m 2 has not been evaluated. ( 1 , 8.8 )
Treatment of heavy menstrual bleeding in females of reproductive potential without organic pathology who choose to use an oral contraceptive as their method of contraception. ( 1.2 ) 1.1 Oral Contraception Natazia ® is indicated for use by women to prevent pregnancy. […]
Conditions named in the indications of dienogest and estradiol's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Natazia), Bayer HealthCare Pharmaceuticals Inc., effective June 26, 2024 (SPL set 02c91fba-9c47-43ef-ac78-e82369798834), via openFDA; the full label on DailyMed
Is there a generic for dienogest and estradiol (Natazia)?
No generic dienogest and estradiol is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 2 patents for Natazia tablets, the last expiring on January 30, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2010 earliest approval on file
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dienogest and estradiol (Natazia)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $8.46 per Natazia 28 tablet, about the same as a year earlier. 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.
- Natazia 28 tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Natazia 28 tablet | Brand | $8.46 per tablet | $253.91 | -0.1% |
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 dienogest and estradiol label say about other medicines?
The dienogest and estradiol label names 17 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 |
|---|---|---|
| Bosentan | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
| Carbamazepine | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
| Clarithromycin | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest. |
| Diltiazem | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest. |
| Erythromycin | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest. |
| Felbamate | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
| Fluconazole | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest. |
| Griseofulvin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
| Itraconazole | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest. |
| Ketoconazole | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of both estradiol and dienogest. |
| Lamotrigine | drug interactions | COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. |
| Oxcarbazepine | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
| Phenytoin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
| Rifampin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
Every other medicine the dienogest and estradiol label names
| Medicine named | Section | What the label says |
|---|---|---|
| Topiramate | drug interactions | … carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
| Verapamil | drug interactions | … (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit increase the serum concentrations of … |
| Voriconazole | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors like azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example … |
Source: FDA drug label (Natazia), Bayer HealthCare Pharmaceuticals Inc., effective June 26, 2024 (SPL set 02c91fba-9c47-43ef-ac78-e82369798834), via openFDA; the full label on DailyMed
What do FAERS reports show for dienogest and estradiol?
The FDA Adverse Event Reporting System holds 316 reports that list dienogest and estradiol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 19 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?
- Dienogest and estradiol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other