Prescription medicine
Ethinyl estradiol and ferrous fumarate and levonorgestrel Brand names: Joyeaux; first approved as Lo/Ovral Fe
Ethinyl estradiol and ferrous fumarate and levonorgestrel (Joyeaux) is a prescription medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $3.45 per joyeaux-28 tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the ethinyl estradiol and ferrous fumarate and levonorgestrel FDA label on DailyMed (effective October 18, 2024, Xiromed, LLC); the NDA 18206 record on Drugs@FDA; every ethinyl estradiol and ferrous fumarate and levonorgestrel label on DailyMed.
Highlights of the record
FDA label of October 18, 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 contraceptive (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 are contraindicated in 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. Joyeaux is contraindicated in women over 35 years old who smoke. ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use.
Used for
From the label: indications and usageJoyeaux is indicated for use by females of reproductive potential to prevent pregnancy.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- July 26, 1979 Lo/Ovral Fe, Cadence Health; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $3.45 per tablet Joyeaux-28 tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5 through July 30, 2026
What is ethinyl estradiol and ferrous fumarate and levonorgestrel used for?
From the label: indications and usageJoyeaux is indicated for use by females of reproductive potential to prevent pregnancy. Joyeaux is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy.
Conditions named in the indications of ethinyl estradiol and ferrous fumarate and levonorgestrel's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Joyeaux), Xiromed, LLC, effective October 18, 2024 (SPL set 655b2c93-cfae-d44f-c128-c816bbd88e45), via openFDA; the full label on DailyMed
What does the patient leaflet for ethinyl estradiol and ferrous fumarate 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 Joyeaux?Do not use Joyeaux 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. This risk increases with age and the number of cigarettes you smoke.
From the patient leaflet: How should I store Joyeaux?Store Joyeaux at room temperature between 68°F to 77°F (20°C to 25°C). • Keep Joyeaux and all medicines out of the reach of children. • Store away from light.
Source: FDA drug label (Joyeaux), Xiromed, LLC, effective October 18, 2024 (SPL set 655b2c93-cfae-d44f-c128-c816bbd88e45), via openFDA; the full label on DailyMed
Is there a generic for ethinyl estradiol and ferrous fumarate and levonorgestrel (Joyeaux)?
No generic ethinyl estradiol and ferrous fumarate and levonorgestrel is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists ethinyl estradiol and ferrous fumarate and levonorgestrel from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1979 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 ethinyl estradiol and ferrous fumarate and levonorgestrel (Joyeaux)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.45 per Joyeaux-28 tablet, down 31% from $5.00 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Joyeaux-28 tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Joyeaux-28 tablet | Generic | $3.45 per tablet | $103.36 | -31% |
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 ethinyl estradiol and ferrous fumarate and levonorgestrel label say about other medicines?
The ethinyl estradiol and ferrous fumarate and levonorgestrel label names 35 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. |
| Aprepitant | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Ascorbic acid | drug interactions | Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. |
| Atazanavir | drug interactions | … lopinavir/ritonavir, tipranavir/ritonavir, boceprevir, telaprevir, nevirapine and efavirenz] or increase [e.g., indinavir, atazanavir/ritonavir and etravirine]). |
| Atorvastatin | drug interactions | Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20-25%. |
| Bosentan | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, 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, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Colesevelam | drug interactions | Colesevelam, a bile acid sequestrant, given together with a COC, has been shown to significantly decrease the AUC of ethinyl estradiol (EE). |
| Cyclosporine | drug interactions | Contraceptives on Other Drugs Combined oral contraceptives containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. |
| Darunavir | drug interactions | … protease inhibitors and non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, boceprevir, telaprevir, nevirapine and efavirenz] or increase [e.g., indinavir, atazanavir/ritonavir and … |
| Efavirenz | drug interactions | … (fos)amprenavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, boceprevir, telaprevir, nevirapine and efavirenz] or increase [e.g., indinavir, atazanavir/ritonavir and etravirine]). |
| Etravirine | drug interactions | … tipranavir/ritonavir, boceprevir, telaprevir, nevirapine and efavirenz] or increase [e.g., indinavir, atazanavir/ritonavir and etravirine]). |
| Felbamate | drug interactions | Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Fluconazole | drug interactions | CYP3A4 inhibitors, such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
Every other medicine the ethinyl estradiol and ferrous fumarate and levonorgestrel label names
| Medicine named | Section | What the label says |
|---|---|---|
| Griseofulvin | drug interactions | … include phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Itraconazole | drug interactions | CYP3A4 inhibitors, such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
| Ketoconazole | drug interactions | CYP3A4 inhibitors, such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
| Lamotrigine | drug interactions | Combined oral contraceptives have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. |
| Lopinavir and ritonavir | drug interactions | Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of co-administration with HIV/HCV protease inhibitors and … |
| Morphine | drug interactions | Combined oral contraceptives have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. |
| Nelfinavir | drug interactions | … and non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, tipranavir/ritonavir, boceprevir … |
| Nevirapine | drug interactions | … lopinavir/ritonavir, tipranavir/ritonavir, boceprevir, telaprevir, nevirapine and efavirenz] or increase [e.g., indinavir, atazanavir/ritonavir and etravirine]). |
| Oxcarbazepine | drug interactions | … phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, 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 … |
| Prednisolone | drug interactions | Contraceptives on Other Drugs Combined oral contraceptives containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) … |
| Rifabutin | drug interactions | … bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Ritonavir | contraindications | … of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions ( 5.3 )] |
| Rosuvastatin | drug interactions | Substances increasing the plasma concentrations of COCs: Co-administration of atorvastatin or rosuvastatin and certain COCs containing EE increase AUC values for EE by approximately 20-25%. |
| Rufinamide | drug interactions | … felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Salicylic acid | drug interactions | Combined oral contraceptives have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. |
| Temazepam | drug interactions | Combined oral contraceptives have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, temazepam and lamotrigine. |
| Theophylline | drug interactions | … the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. |
| Tizanidine | drug interactions | … of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. |
| Topiramate | drug interactions | … carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. |
| Voriconazole | drug interactions | CYP3A4 inhibitors, such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations. |
Check ethinyl estradiol and ferrous fumarate and levonorgestrel against other medicines
Source: FDA drug label (Joyeaux), Xiromed, LLC, effective October 18, 2024 (SPL set 655b2c93-cfae-d44f-c128-c816bbd88e45), via openFDA; the full label on DailyMed
What do FAERS reports show for ethinyl estradiol and ferrous fumarate and levonorgestrel?
The FDA Adverse Event Reporting System holds 5 reports that list ethinyl estradiol and ferrous fumarate and levonorgestrel 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 1 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?
- Ethinyl estradiol and ferrous fumarate and levonorgestrel side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other