Prescription medicine
Drospirenone and estradiol Brand names: Angeliq
Drospirenone and estradiol (Angeliq) is a prescription medicine with an FDA approval on record since 2005. No generic is listed; pharmacies paid $6.37 per Angeliq 0.25 mg-0.5 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the drospirenone and estradiol FDA label on DailyMed (effective March 2, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 21355 record on Drugs@FDA; every drospirenone and estradiol label on DailyMed.
Highlights of the record
FDA label of March 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER,.
and ENDOMETRIAL CANCER Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of pulmonary embolism (PE), deep vein thrombosis (DVT), stroke, and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.5) ]. The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.4), Use in Specific Populations (8.5), and Clinical Studies (14.5) ]. Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1 , 5.4), Clinical Studies (14.4 , 14.5) ]. […]
Used for
From the label: indications and usageUse estrogen, alone or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman.
Forms and strengths
- 0.5 mg / 0.25 mg
- 1 mg / 0.5 mg
Film-coated tablet.
On the market
- Earliest approval on file
- September 28, 2005 Angeliq, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first October 28, 2025; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 22, 2031 Angeliq tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $6.37 per tablet Angeliq 0.25 mg-0.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 538 through July 30, 2026
What is drospirenone and estradiol used for?
From the label: indications and usageUse estrogen, alone or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Re-evaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary. Angeliq is a combination of an estrogen and progestin indicated in a woman with a uterus for the treatment of: Moderate to severe vasomotor symptoms due to menopause. ( 1.1 ) Moderate to severe vulvar and vaginal atrophy symptoms due to menopause. […]
Conditions named in the indications of drospirenone and estradiol's FDA labels, with every medicine labeled for each:
From other drospirenone and estradiol labelsMenopause symptoms: Moderate to Severe Vasomotor Symptoms due to Menopause Angeliq 0.25 mg drospirenone (DRSP)/0.5 mg estradiol (E2) is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause in a woman with a uterus.
Source: FDA drug label (Angeliq), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 761834c2-6b61-4583-84c2-f1ca4a97c4f2), via openFDA; the full label on DailyMed
What does the patient leaflet for drospirenone and estradiol 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 Angeliq (a combination of estrogen and progestogen)?Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (declines of brain function). Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots. Using estrogens with progestogen may increase your chance of getting dementia, based on a study of women 65 years of age and older Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Do not use estrogen-alone to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function). Using estrogen-alone may increase your chances of getting strokes or blood clots Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age and older Only one estrogen with progestogen product and dose have been shown to increase your chances of getting heart attacks, strokes, breast cancer, and dementia. Only one estrogen-alone product and dose have been shown to increase your chances of getting strokes, blood clots, and dementia. Because other products and doses have not been studied in the same way, it is not known how the use of Angeliq will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Angeliq.
From the patient leaflet: How should I store Angeliq?Store Angeliq at room temperature between 68˚F to 77˚F (20˚C to 25˚C). Keep Angeliq and all medicines out of the reach of children. What can I do to lower my chances of a serious side effect with Angeliq? Talk with your healthcare provider regularly about whether you should continue using Angeliq. If you have a uterus, talk with your healthcare provider about whether Angeliq is right for you. In general, the addition of a progestogen is recommended for a women with a uterus to reduce the chances of getting cancer of the uterus (womb). See your healthcare provider right away if you get vaginal bleeding while using Angeliq. Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else. […]
Source: FDA drug label (Angeliq), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 761834c2-6b61-4583-84c2-f1ca4a97c4f2), via openFDA; the full label on DailyMed
Is there a generic for drospirenone and estradiol (Angeliq)?
The FDA approved the first generic drospirenone and estradiol on October 28, 2025. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 1 patent for Angeliq tablets, the last expiring on October 22, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2005 earliest approval on file
- 2025 first generic approved
- 2031 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 estradiol (Angeliq)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $6.37 per Angeliq 0.25 mg-0.5 mg 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.
- Angeliq 0.5 mg-1 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Angeliq 0.25 mg-0.5 mg tablet | Brand | $6.37 per tablet | $191.03 | -0.1% |
| Angeliq 0.5 mg-1 mg tablet | Brand | $6.37 per tablet | $191.00 | +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 drospirenone and estradiol label say about other medicines?
The drospirenone and estradiol label names 18 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 |
|---|---|---|
| Carbamazepine | drug interactions | … progestins (enzyme inducers) Inducers of CYP3A4 such as St. John's wort ( Hypericum perforatum ), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens and progestins, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. … |
| Clarithromycin | drug interactions | … (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit juice did increase the plasma concentrations of the estrogen or the progestin or both [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) … |
| Diltiazem | drug interactions | … itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit juice did increase the plasma concentrations of the estrogen or the progestin or both [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ]. … |
| Enalapril | drug interactions | A drug-drug interaction study of DRSP 3 mg/E2 1 mg versus placebo was performed in mildly hypertensive postmenopausal women taking enalapril maleate 10 mg twice daily. |
| Erythromycin | drug interactions | … ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit juice did increase the plasma concentrations of the estrogen or the progestin or both [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ]. … |
| Fluconazole | drug interactions | … strong CYP3A4 inhibitors such as azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit juice did increase the plasma concentrations of the estrogen or the progestin or both [see Warnings and … |
| Heparin | warnings and precautions | … potassium supplements, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, heparin and aldosterone antagonists. |
| Itraconazole | drug interactions | … administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit juice did increase the plasma concentrations of the estrogen or the … |
| Ketoconazole | drug interactions | In a clinical drug-drug interaction study conducted in premenopausal women, once daily co-administration of DRSP 3 mg/E2 1.5 mg containing tablets with strong CYP3A4 inhibitor, ketoconazole 200 mg twice daily for 10 days resulted in a moderate increase of exposure and a mild increase of peak concentration for DRSP. |
| Medroxyprogesterone | boxed warning | … years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.5) ]. |
| Midazolam | drug interactions | Two further clinical drug-drug interaction studies using simvastatin and midazolam as marker substrates for CYP3A4, respectively, were performed and the results of these studies demonstrated that pharmacokinetics of the CYP3A4 substrates were not influenced by steady-state DRSP concentrations. |
| Omeprazole | drug interactions | No significant effect of DRSP on the systemic clearance of the CYP3A4 product omeprazole sulfone was found. |
| Phenobarbital | drug interactions | … estrogens and progestins (enzyme inducers) Inducers of CYP3A4 such as St. John's wort ( Hypericum perforatum ), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens and progestins, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding … |
| Rifampin | drug interactions | … inducers) Inducers of CYP3A4 such as St. John's wort ( Hypericum perforatum ), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens and progestins, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. … |
Every other medicine the drospirenone and estradiol label names
| Medicine named | Section | What the label says |
|---|---|---|
| Simvastatin | drug interactions | Two further clinical drug-drug interaction studies using simvastatin and midazolam as marker substrates for CYP3A4, respectively, were performed and the results of these studies demonstrated that … |
| Testosterone | warnings and precautions | Free hormone concentrations, such as testosterone and estradiol, may be decreased. |
| Verapamil | drug interactions | … (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit juice did increase the plasma … |
| Voriconazole | drug interactions | … such as azole antifungals (for example, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (for example, clarithromycin, erythromycin), diltiazem, and grapefruit juice did … |
Source: FDA drug label (Angeliq), Bayer HealthCare Pharmaceuticals Inc., effective March 2, 2026 (SPL set 761834c2-6b61-4583-84c2-f1ca4a97c4f2), via openFDA; the full label on DailyMed
What do FAERS reports show for drospirenone and estradiol?
The FDA Adverse Event Reporting System holds 538 reports that list drospirenone and estradiol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 102 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as drospirenone and estradiol?
5 other medicines are given the same way (oral) and in the same FDA class as drospirenone and estradiol or labeled mainly for the same use (menopause symptoms), the same class first. Menopause symptoms lists all 11 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Ethinyl estradiol and norethindrone | Menopause symptoms | 15 labelers | $0.181 per tablet 21 1-20 tablet | No current entry |
| Estrogens conjugated | Menopause symptoms | 1 labeler | $5.47 per tablet 0.625 mg tablet | No current entry |
| Fezolinetant | Menopause symptoms | none listed | $18.58 per tablet 45 mg tablet | No current entry |
| Elinzanetant | Menopause symptoms | none listed | $9.97 per capsule 60 mg capsule | No current entry |
| Ospemifene | Menopause symptoms | none listed | $8.17 per tablet 60 mg tablet | No current entry |
Every medicine labeled for the same conditions as drospirenone and estradiol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to drospirenone and estradiol
- 5 medicines for the same use
- Other estrogens
- the pharmacologic class, with prices and generics
- Drospirenone and estradiol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other