Prescription medicine
Estradiol and levonorgestrel Brand names: Climara; first approved as Climara Pro
Estradiol and levonorgestrel (Climara) is a prescription medicine with an FDA approval on record since 2003. No generic is listed; pharmacies paid $59.64 per Climara pro patch in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the estradiol and levonorgestrel FDA label on DailyMed (effective March 26, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 21258 record on Drugs@FDA; every estradiol and levonorgestrel label on DailyMed.
Highlights of the record
FDA label of March 26, 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 an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), 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 (5.3), Use in Specific Populations (8.5), and Clinical Studies (14.6) ]. Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1 , 5.3), and Clinical Studies (14.5 , 14.6) ]. […]
Used for
From the label: indications and usageClimara Pro is indicated for: Climara Pro is an estrogen plus progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Prevention of Postmenopausal Osteoporosis ( 1.2 ) Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications.
Forms and strengths
- 0.045 mg / 0.015 mg
Patch.
On the market
- Earliest approval on file
- November 21, 2003 Climara Pro, Bayer Hlthcare; 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
Supply and safety
- Pharmacy cost (NADAC)
- $59.64 per patch Climara pro patch
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,021 through July 30, 2026
What is estradiol and levonorgestrel used for?
From the label: indications and usageClimara Pro is indicated for: Climara Pro is an estrogen plus progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) Prevention of Postmenopausal Osteoporosis ( 1.2 ) Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. […]
Conditions named in the indications of estradiol and levonorgestrel's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Estrogen, Progestin and Progestin-containing Intrauterine System.
Source: FDA drug label (Climara Pro), Bayer HealthCare Pharmaceuticals Inc., effective March 26, 2026 (SPL set 184d3092-7fc6-4375-816b-1ab06bb99cfd), via openFDA; the full label on DailyMed
What does the patient leaflet for estradiol and levonorgestrel 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 Climara Pro (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 progestogens 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. 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, blood clots, 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 Climara Pro will affect your chances of these conditions. You and your healthcare provider should talk regularly about whether you still need treatment with Climara Pro.
From the patient leaflet: How should I store and throw away used Climara Pro?Store at room temperature between 68°F to 77°F (20°C to 25°C). Do not store Climara Pro patches outside of their pouches. Apply immediately after removal from the protective pouch. Used patches still contain estrogen. To throw away the patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place this container in the trash. Used patches should not be flushed in the toilet. KEEP CLIMARA PRO and all medicines out of the reach of children.
Source: FDA drug label (Climara Pro), Bayer HealthCare Pharmaceuticals Inc., effective March 26, 2026 (SPL set 184d3092-7fc6-4375-816b-1ab06bb99cfd), via openFDA; the full label on DailyMed
Is there a generic for estradiol and levonorgestrel (Climara)?
No generic estradiol and levonorgestrel is approved (Drugs@FDA, October 8, 2026).
- 2003 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for estradiol and levonorgestrel (Climara)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $59.64 per Climara pro patch, 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.
- Climara pro patch (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Climara pro patch | Brand | $59.64 per patch | n/a | -0.2% |
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 estradiol and levonorgestrel label say about other medicines?
The estradiol and levonorgestrel label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name estradiol and levonorgestrel. 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 | Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. |
| Clarithromycin | drug interactions | Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. |
| Erythromycin | drug interactions | Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. |
| Itraconazole | drug interactions | Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. |
| Ketoconazole | drug interactions | Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. |
| 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) ]. |
| Phenobarbital | drug interactions | Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. |
| Rifampin | drug interactions | Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. |
| Ritonavir | drug interactions | Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. |
| Testosterone | warnings and precautions | Free hormone concentrations, such as testosterone and estradiol, may be decreased. |
Source: FDA drug label (Climara Pro), Bayer HealthCare Pharmaceuticals Inc., effective March 26, 2026 (SPL set 184d3092-7fc6-4375-816b-1ab06bb99cfd), via openFDA; the full label on DailyMed
What do FAERS reports show for estradiol and levonorgestrel?
The FDA Adverse Event Reporting System holds 2,021 reports that list estradiol and levonorgestrel among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 14 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 next?
- Other estrogens
- the pharmacologic class, with prices and generics
- Estradiol and levonorgestrel side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other