Prescription medicine
Drospirenone and ethinyl estradiol and levomefolate Brand names: Safyral, Beyaz, Tydemy
Drospirenone and ethinyl estradiol and levomefolate (Beyaz) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $1.38 per unit (Drosp-ee-levomef 3-0.02-0.451) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the drospirenone and ethinyl estradiol and levomefolate FDA label on DailyMed (effective March 4, 2026, Bayer HealthCare Pharmaceuticals Inc.); the NDA 22532 record on Drugs@FDA; every drospirenone and ethinyl estradiol and levomefolate label on DailyMed.
Highlights of the record
FDA label of March 4, 2026; 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 Safyral. ( 4 )
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
Used for
From the label: indications and usageSafyral is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to:
Prevent pregnancy.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- September 24, 2010 Beyaz, Bayer Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first October 11, 2016; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- July 17, 2030 Beyaz tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.38 per unit Drosp-ee-levomef 3-0.02-0.451
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2021 1 Class I among all firms' recalls; latest June 23, 2023
- FAERS reports
- 1,809 through July 30, 2026
What is drospirenone and ethinyl estradiol and levomefolate used for?
From the label: indications and usageSafyral is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to:
Prevent pregnancy. ( 1.1 )
Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. […]
Conditions named in the indications of drospirenone and ethinyl estradiol and levomefolate's FDA labels, with every medicine labeled for each:
From other drospirenone and ethinyl estradiol and levomefolate labelsBirth control: Safyral is indicated for use by females of reproductive potential to prevent pregnancy.
Acne: Treat moderate acne for females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control.
Source: FDA drug label (Safyral), Bayer HealthCare Pharmaceuticals Inc., effective March 4, 2026 (SPL set 97563516-306a-4e17-9690-edbda49ecd83), via openFDA; the full label on DailyMed
Is there a generic for drospirenone and ethinyl estradiol and levomefolate (Beyaz)?
The FDA approved the first generic drospirenone and ethinyl estradiol and levomefolate on October 11, 2016. 4 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists drospirenone and ethinyl estradiol and levomefolate from 1 labeler under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Beyaz tablets, the last expiring on July 17, 2030. 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
- 2016 first generic approved
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for drospirenone and ethinyl estradiol and levomefolate (Beyaz)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.38 per unit (Drosp-ee-levomef 3-0.02-0.451), down 1% from $1.40 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.
- Drosp-ee-levomef 3-0.02-0.451 (generic)
- Beyaz 28 tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Drosp-ee-levomef 3-0.02-0.451 | Generic | $1.38 per unit | n/a | -1% |
| Drosp-ee-levomef 3-0.03-0.451 | Generic | $2.96 per unit | n/a | -15% |
| Tydemy 3-0.03-0.451 mg tablet | Generic | $2.96 per tablet | $88.79 | n/a |
| Beyaz 28 tablet | Brand | $8.30 per tablet | $248.94 | -0.6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has drospirenone and ethinyl estradiol and levomefolate been recalled?
The FDA's Enforcement Report lists 2 recalls naming drospirenone and ethinyl estradiol and levomefolate since 2021: 1 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 23, 2023 | Class I | Lupin Pharmaceuticals Inc. | Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity … |
| November 19, 2021 | Class III | Lupin Pharmaceuticals Inc. | Subpotent Drug |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the drospirenone and ethinyl estradiol and levomefolate label say about other medicines?
The drospirenone and ethinyl estradiol and levomefolate label names 39 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 |
|---|---|---|
| Acetaminophen | drug interactions | Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. |
| Ascorbic acid | drug interactions | Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. |
| Atorvastatin | drug interactions | Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin with certain COCs containing EE increase AUC values for EE by approximately 20%. |
| 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. |
| Cholestyramine | drug interactions | Drugs on Folates Several drugs have been reported to reduce folate concentrations by inhibition of the dihydrofolate reductase enzyme (e.g., methotrexate and sulfasalazine) or by reducing folate absorption (e.g., cholestyramine), or via unknown mechanisms (e.g., antiepileptics such as carbamazepine, phenytoin … |
| Clarithromycin | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g., clarithromycin, erythromycin), diltiazem, and grapefruit juice can increase the plasma concentrations of the estrogen or the progestin … |
| Diltiazem | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g., clarithromycin, erythromycin), diltiazem, and grapefruit juice can increase the plasma concentrations of the estrogen or the progestin … |
| Divalproex | drug interactions | Drugs on Folates Several drugs have been reported to reduce folate concentrations by inhibition of the dihydrofolate reductase enzyme (e.g., methotrexate and sulfasalazine) or by reducing folate absorption (e.g., cholestyramine), or via unknown mechanisms (e.g., antiepileptics such as carbamazepine, phenytoin … |
| Erythromycin | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g., clarithromycin, erythromycin), diltiazem, and grapefruit juice can increase the plasma concentrations of the estrogen or the progestin … |
| 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 such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g., clarithromycin, erythromycin), diltiazem, and grapefruit juice can increase the plasma concentrations of the estrogen or the progestin … |
| 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. |
| Heparin | warnings and precautions | Medications that may increase serum potassium concentration include ACE inhibitors, angiotensin–II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs. |
Every other medicine the drospirenone and ethinyl estradiol and levomefolate label names
| Medicine named | Section | What the label says |
|---|---|---|
| Itraconazole | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g. … |
| Ketoconazole | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g. … |
| Lamotrigine | drug interactions | COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. |
| Levonorgestrel | warnings and precautions | … a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. |
| Medroxyprogesterone | warnings and precautions | … norgestimate, norethindrone, levonorgestrel, desogestrel, norgestrel, medroxyprogesterone, or ethynodiol diacetate; Hazard Ratio (HR) (95% CI): HR: 0.9 (0.5-1.6) |
| Methotrexate | drug interactions | … certain antifolate drugs, e.g., antiepileptics (such as phenytoin), methotrexate or pyrimethamine, and may result in a decreased pharmacological effect of the antifolate drug. |
| Midazolam | drug interactions | … weak increase in plasma concentrations of CYP3A4 substrates (e.g., midazolam) while plasma concentrations of CYP2C19 substrates (e.g., omeprazole and voriconazole) and CYP1A2 substrates (e.g. … |
| Norethindrone | warnings and precautions | … Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, levonorgestrel, desogestrel, norgestrel, medroxyprogesterone, or ethynodiol diacetate; … |
| Norgestrel | warnings and precautions | … containing the following progestins: norgestimate, norethindrone, levonorgestrel, desogestrel, norgestrel, medroxyprogesterone, or ethynodiol diacetate; Hazard Ratio (HR) (95% CI): HR: 0.9 (0.5-1.6) |
| Omeprazole | drug interactions | … midazolam) while plasma concentrations of CYP2C19 substrates (e.g., omeprazole and voriconazole) and CYP1A2 substrates (e.g., theophylline and tizanidine) can have a weak or moderate increase. |
| Oxcarbazepine | drug interactions | … phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
| Phenobarbital | drug interactions | … mechanisms (e.g., antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone and valproic acid). |
| Phenytoin | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine … |
| Primidone | drug interactions | … (e.g., antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone and valproic acid). |
| Pyrimethamine | drug interactions | … antifolate drugs, e.g., antiepileptics (such as phenytoin), methotrexate or pyrimethamine, and may result in a decreased pharmacological effect of the antifolate drug. |
| Rifampin | drug interactions | … barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
| Ritonavir | contraindications | 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 ( 5.5 ) and Drug … |
| Spironolactone | warnings and precautions | … hyperkalemia in high-risk patients, comparable to a 25 mg dose of spironolactone. |
| Sulfasalazine | drug interactions | … inhibition of the dihydrofolate reductase enzyme (e.g., methotrexate and sulfasalazine) or by reducing folate absorption (e.g., cholestyramine), or via unknown mechanisms (e.g., antiepileptics such … |
| Theophylline | drug interactions | … substrates (e.g., omeprazole and voriconazole) and CYP1A2 substrates (e.g., theophylline and tizanidine) can have a weak or moderate increase. |
| Tizanidine | drug interactions | … omeprazole and voriconazole) and CYP1A2 substrates (e.g., theophylline and tizanidine) can have a weak or moderate increase. |
| Topiramate | drug interactions | … carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate and products containing St. John’s wort. |
| Valproic acid | drug interactions | … antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone and valproic acid). |
| Verapamil | drug interactions | … antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g., clarithromycin, erythromycin), diltiazem, and grapefruit juice can increase the plasma … |
| Voriconazole | drug interactions | Concomitant administration of moderate or strong CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g. … |
Check drospirenone and ethinyl estradiol and levomefolate against other medicines
Source: FDA drug label (Safyral), Bayer HealthCare Pharmaceuticals Inc., effective March 4, 2026 (SPL set 97563516-306a-4e17-9690-edbda49ecd83), via openFDA; the full label on DailyMed
What do FAERS reports show for drospirenone and ethinyl estradiol and levomefolate?
The FDA Adverse Event Reporting System holds 1,809 reports that list drospirenone and ethinyl estradiol and levomefolate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 25 are coded as a death and 505 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?
- Drospirenone and ethinyl estradiol and levomefolate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other