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levonorgestrel / ethinyl estradiol / ferrous bisglycinate

Generic Balcoltra
Used for Birth Control
Used for Birth Control

Balcoltra is a combined oral contraceptive (COC), or birth control. It contains 3 medications: levonorgestrel (a progestin), ethinyl estradiol (an estrogen), and ferrous bisglycinate (an iron supplement). Balcoltra is taken by mouth once daily. Each 28-day pack of Balcoltra contains 21 active (hormone) pills and 7 placebo pills. Balcoltra is a monophasic birth control, meaning each active pill contain the same amount of hormones. Some side effects of this COC include headache, abnormal bleeding, and period cramping. Balcoltra is available as a generic called Joyeaux.

Reviewed by:
reviewer
Ally Tsai, PharmD
reviewer
Connie Zheng, PharmD
Last reviewed on August 26, 2024
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageCostContraindicationsAlternativesReferencesPricesMedicare
basics-icon

What is Balcoltra?

What is Balcoltra used for?

How Balcoltra works

Balcoltra is a combination of two hormones, levonorgestrel (a progestin) and ethinyl estradiol (an estrogen). These two hormones work together to help prevent pregnancy by:

  • Stopping ovulation (release of an egg from the ovary)

  • Thickening cervical mucus (fluid from the cervix), which makes it hard for sperm to move and fertilize an egg

  • Thinning the lining of the uterus (womb) so a fertilized egg can't implant

Balcoltra also contains ferrous bisglycinate, an iron supplement.

Are you looking for information on Vienva (levonorgestrel / ethinyl estradiol) monophasic or Amethyst (levonorgestrel / ethinyl estradiol) continuous cycle instead?

Drug Facts

Common BrandsBalcoltra, Joyeaux, Minzoya
Drug ClassEstrogen / Progestin combined contraceptive
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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Avg retail price
$266.720
GoodRx discount
$266.72
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basics-icon

What are the side effects of Balcoltra?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Headache (14%)
  • Abnormal bleeding (8%)
  • Period cramps (7%)
  • Nausea (7%)
  • Stomach pain (4%)
  • Breast pain (4%)

Other Side Effects

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Heart attack: chest pain, belly discomfort, sweating, nausea, dizziness
  • Stroke: sudden numbness or weakness in the arm, leg, or face, confusion, trouble seeing, headache, difficulty walking
  • Deep vein thrombosis (blood clot in the leg): leg cramp, swelling, pain, muscle tightness
  • Pulmonary embolism (blood clot in the lung): cough, chest pain, trouble breathing, racing heart
  • Liver or gallbladder problems: yellowing of the skin or the whites of the eyes, tiredness, pain in the right upper stomach, dark urine

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

  • Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
  • Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
  • Gallbladder problems—severe stomach pain, nausea, vomiting, fever
  • Increase in blood pressure
  • Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
  • New or worsening migraines or headaches
  • Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
  • Unusual vaginal discharge, itching, or odor
  • Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

  • Breast pain or tenderness
  • Dark patches of skin on the face or other sun-exposed areas
  • Irregular menstrual cycles or spotting
  • Nausea
  • Weight gain
pros-and-cons

Pros and cons of Balcoltra

thumbs-up

Pros

Taken by mouth

Taken once daily

Placebo (hormone-free) pills contain an iron supplement

Available as a generic

thumbs-down

Cons

Doesn't protect against sexually transmitted diseases (STDs)

Can cause unpleasant side effects, like headache and abnormal bleeding

Can't be used by females over 35 who smoke because of risk of blood clots

Not appropriate for people allergic to FD&C Yellow No. 5 (tartrazine)

pharmacist-tips

Pharmacist tips for Balcoltra

pharmacist

  • Balcoltra isn't an emergency contraception (morning-after pill) and shouldn't be used after unprotected sex to prevent pregnancy. Talk to your gynecologist or pharmacist if you had unprotected sex and need an emergency contraception, such as levonorgestrel (Plan B One-Step) or Ella (ulipristal).

    • Try to take Balcoltra around the same time every day. Consider setting an alarm to remind yourself to take your doses at the scheduled time.

      • If you missed one active Balcoltra tablet, take your missed dose as soon as possible. Then, take your next scheduled dose at the regular time. You might need to take two tablets in one day. If you've missed more than one tablet in a blister pack, refer to the instructions that came with your pack or call your gynecologist or pharmacist for further instructions.

        • You might experience irregular bleeding while taking Balcoltra. For some people, this means having heavier periods. But for others, this could mean missing periods or having breakthrough bleeding. Continue to take Balcoltra every day as directed by your gynecologist. Speak with your gynecologist if you're concerned about changes in your period.

          • Let your gynecologist know if you experience symptoms of depression or worsening mood while taking Balcoltra. In cases of serious depression, your gynecologist might ask you to stop taking this medication.

            • If you've had a skin condition that causes brownish patches on your skin, these patches can reappear or darken while taking Balcoltra. Avoid exposing your skin to the sun or ultraviolet radiation (e.g., tanning booths, sun lamps) while you're taking this medication.

              • Let your healthcare team know if you're scheduled to have surgery while taking Balcoltra. Because taking COCs can raise your risk of blood clots after surgery, your healthcare team will likely ask you to stop taking Balcoltra at least a month before your surgery, and not restart treatment until at least 2 weeks after your surgery.

                • Get immediate medical attention if you notice symptoms of a blood clot, including trouble catching your breath, leg pain that won't go away, or sudden and severe headache. Though rare, taking COCs, including Balcoltra, can raise the risk for blood clots.

                  • Call 911 if you experience sudden swelling around the face, lips, or throat that makes it hard for you to breathe. Though rare, Balcoltra and other birth control pills can trigger a reaction called angioedema, especially in people who've had similar reactions in the past.

                    faqs

                    Frequently asked questions about Balcoltra

                    How effective is Balcoltra?
                    If you take Balcoltra at the same time every day without missing any pills, it's about 99% effective at preventing pregnancy. But if you're miss a pill here and there, Balcoltra is about 91% successful at preventing pregnancy. Be aware that your chance of getting pregnant is higher if you don't take this medication according to your gynecologist's directions or if you frequently miss doses. If you've trouble remembering to take your medication, consider setting an alarm or organize your medications with a pill box.
                    How much estrogen is in Balcoltra?
                    Balcoltra contains 20 mcg of ethinyl estradiol. In general, COCs that contain 20 mcg of ethinyl estradiol or less are considered low-dose estrogen COCs. Talk with your healthcare team if you have more questions about the dose of estrogen in Balcoltra.
                    Is Balcoltra a combination pill?
                    Yes, Balcoltra is a combination oral contraceptive (COC). The active pills contain both levonorgestrel (a progestin) and ethinyl estradiol (an estrogen) that work together to prevent pregnancy. But Balcoltra placebo pills only contain ferrous bisglycinate, which is an iron supplement.
                    Does Balcoltra cause weight gain?
                    Though rare, a few people did report weight gain while taking Balcoltra in clinical studies. But it's unclear whether the weight gain was caused by Balcoltra or by other factors. In general, studies show that birth control pills aren't likely to cause weight gain. People who do experience weight gain are more likely to do so from the body holding onto more water (water retention), rather than from an increase in body fat. Talk with your healthcare team if you're concerned about Balcoltra and weight gain.
                    Does Balcoltra stop periods?
                    In general, you can expect to have a period every 28-day cycle, during the week when you're taking Balcoltra placebo pills. But you might notice changes to your periods when taking Balcoltra, especially during the first few months after you start. In clinical studies, people who took Balcoltra reported both heavier menstrual bleeding and missing periods as side effects. It's possible to miss a period while taking Balcoltra, even if you're not pregnant. If you're concerned about a missed period or any other changes in menstrual bleeding, talk with your healthcare team.
                    Does Balcoltra help acne?
                    Balcoltra is only FDA-approved to prevent pregnancy, not help with acne. Though not common, some people reported experiencing acne as a side effect after starting Balcoltra. But in general, birth control pills that contain estrogen can help with acne. This is because estrogen lowers the amount of testosterone in the body, and having less testosterone can improve hormonal acne. In fact, there are a few COCs that are FDA-approved treat acne, including Yaz (drospirenone / ethinyl estradiol) and Tri-Sprintec (norgestimate / ethinyl estradiol). Talk with your healthcare team if you've more questions about how Balcoltra might affect acne.
                    What's similar to Balcoltra?
                    While Balcoltra is the brand name birth control, there are other branded generic birth controls similar to Balcoltra that have the same active ingredients, use, side effects, and dose. One example is Joyeaux. Joyeaux is a monophasic birth control with the same doses of levonorgestrel and ethinyl estradiol. One difference between the birth control pills is that Joyeaux placebo tablets contain 75 mg ferrous fumarate while Balcoltra placeo tablets contain 36.5 mg ferrous bisglycinate. In addition, Joyeaux might be a lower-cost alternative to Balcoltra.
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                    warings-icon

                    What are the risks and warnings for Balcoltra?

                    Balcoltra can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

                    risk-warning

                    Cigarette smoking and serious heart problems

                    • Risk factors: Females over 35 years old who smoke cigarettes

                      Smoking cigarettes while taking COCs, like Balcoltra, can significantly raise the risk of serious heart problems, including heart attack and stroke. The risk is greater if you're over 35 years old. If you smoke, talk with your gynecologist about safer birth control alternatives.

                      risk-warning

                      Risk of blood clot

                      • Risk factors: Females over 35 years old who smoke | Females over 40 years old who don't smoke | Recent surgery with a long period of bed rest | Starting COCs less than a month after childbirth | High blood pressure | People identified as obese | High cholesterol | Diabetes | Higher dose of estrogen | First year of using COCs | Restarting COCs after a month

                        Balcoltra can raise the risk of serious blood clots because it contains ethinyl estradiol (an estrogen). More estrogen can lead to more blood proteins that stimulate clot formation. These blood clots can be life-threatening and can happen anywhere in your body. Get medical attention right away if you have any signs or symptoms of a blood clot:

                        • Brain (e.g., stroke): weakness or numbness in your arms, legs, or face on one side of the body, trouble speaking, blurry vision, dizziness, loss of balance, trouble walking, or confusion

                          • Eyes (e.g., retinal thrombosis): trouble seeing, bulging eye, double vision

                            • Heart (e.g., heart attack): chest pain, sweating, nausea, or dizziness

                              • Lungs (e.g., pulmonary embolism or PE): trouble breathing, chest pain, or cough

                                • Legs (e.g., deep vein thrombosis or DVT): cramps, swelling, pain, or muscle tightness

                                  Your risk of getting a blood clot is higher if you're older, smoke cigarettes, or have certain medical conditions. Your risk is also higher if you're on bedrest after surgery or if you've just given birth. Typically your gynecologist will temporarily stop Balcoltra for 3-4 weeks before surgery, then restart it 2 weeks after. If you recently delivered a baby, you shouldn't start this medication until 4 weeks after delivery and if you're not breastfeeding. Talk with your gynecologist if you have any questions regarding your risk of blood clots.

                                  risk-warning

                                  Breast and cervical cancer

                                  • Risk factors: History of breast or cervical cancer | Taking COCs for a long time | Taken COCs in the last 6 months

                                    It's not clear whether Balcoltra and other COCs can significantly raise your risk for breast and cervical cancer. Research shows that people who used COCs for more than 5 years seemed to be at a greater risk for cervical cancer than those who never used these medications. In addition, certain breast cancer cells grow faster in the presence of estrogen. Since there's a risk of serious harm, don't take Balcoltra if you currently have or have had breast cancer or cervical cancer. If you currently take this medication or have taken it in the last 6 months, make sure to get a yearly breast exam with your gynecologist to check for early signs of breast cancer. Your gynecologist can also make sure you get appropriate screenings for cervical cancer. Let your gynecologist know if you notice any signs of breast cancer (e.g., new or abnormal lumps, pain, or swelling in your breasts) or cervical cancer (e.g., vaginal bleeding or discharge that's not normal).

                                    risk-warning

                                    Liver problems

                                    • Risk factors: Taking COCs for more than 8 years | Certain hepatitis C medications

                                      Don't take Balcoltra if you have liver problems, such as liver infection caused by a virus (e.g., hepatitis), cirrhosis (scarring of the liver) or liver tumors. Although rare, this medication can raise your risk of getting benign liver tumors. If you experience signs of liver problems, you should stop taking Balcoltra and ask your gynecologist for an alternative birth control. Signs of liver problems can include jaundice (yellowing of the skin or whites of the eyes), fever, tiredness, loss of appetite, or dark colored urine.

                                      Additionally, Balcoltra shouldn’t be taken together with Viekira Pak, a hepatitis C medication contains ombitasvir, paritaprevir, and ritonavir. Doing so can cause liver problems. You can restart Balcoltra two weeks after completing hepatitis C treatment.

                                      risk-warning

                                      Gallbladder problems

                                      Some studies suggest that Balcoltra can raise the risk of gallbladder disease since more progestin and estrogen can lead to higher chance of gallstones. Although the risk is low, talk to your gynecologist if you a history of gallbladder disease before starting Balcoltra.

                                      risk-warning

                                      High blood sugar and triglycerides

                                      • Risk factors: High blood sugar | High triglycerides

                                        Balcoltra can raise your levels of blood sugar and triglycerides (a type of fat). Your risk is higher if you already have high blood sugar levels. This is because Balcoltra can prevent your body from breaking down sugar properly.

                                        Additionally, this medication can raise your triglycerides levels and put you at risk for pancreatitis (pancreas inflammation). Speak with your gynecologist before starting Balcoltra if you have a history of high blood sugar or triglycerides. Your gynecologist might help you choose another birth control or monitor your blood work more closely if you take this medication.

                                        risk-warning

                                        High blood pressure

                                        • Risk factors: Older age | Using COCs for a long time | History of high blood pressure | Kidney problems

                                          Balcoltra can raise your blood pressure, so make sure you check your blood pressure while you're taking this medication. The risk is higher if you're older and have been taking birth control for a long period of time. If you have a history of kidney problems or high blood pressure that's not controlled, don't use this medication. Talk with your gynecologist so you can discuss the benefits and risks of taking Balcoltra.

                                          risk-warning

                                          Headache

                                          Let your gynecologist know if you experience new or worsening migraines or headaches while taking Balcoltra. You might need to stop your medication if your migraine or headache doesn't go away or becomes severe.

                                          risk-warning

                                          Irregular bleeding

                                          • Risk factor: First 3 months of COCs

                                            People who take Balcoltra can sometimes experience irregular bleeding and spotting, especially during the first 3 months of taking this medication. Irregular bleeding can vary from slight staining to bleeding similar to a regular period. This problem is often temporary, so continue taking your medication as directed. If your bleeding doesn't stop, becomes heavier, or you miss a period after the initial bleeding, let your gynecologist know. Your gynecologist can perform blood tests to rule out other potential causes for bleeding.

                                            risk-warning

                                            Interaction with other medications

                                            Some medications can interfere with how your body gets rid of Balcoltra. This can affect the amount of Balcoltra in your body, how well it works, and the risk of side effects.

                                            Taking medications like rosuvastatin (Crestor) or atorvastatin (Lipitor) can raise the amount of Balcoltra in your body, which can cause a higher risk of side effects.

                                            Taking medications like carbamazepine (Tegretol) or topiramate can lower the amount of Balcoltra in your body. This can cause your birth control to not work as well. Use a condom when you take these medications together and for 28 days after stopping carbamazepine (Tegretol) or topiramate.

                                            Balcoltra also interferes with how your body gets rid of other medications. For example, it shouldn’t be taken with lamotrigine (Lamictal). Doing so can drop levels of lamotrigine (Lamictal) in your body and raise your risk for seizures or mood changes.

                                            If you take Balcoltra and a medication to replace your thyroid hormone, such as levothyroxine (Synthroid), you might need to take a higher dose of your thyroid medication since Balcoltra can cause it to not work as well.

                                            Let your gynecologist or pharmacist know what other medications you’re taking before and while taking Balcoltra.

                                            dosage

                                            Balcoltra dosage forms

                                            The average cost for 1 package of 28 tablets of 0.1mg/0.02mg/36.5mg of Balcoltra is $271.83 with a free GoodRx coupon. This is 20.57% off the average retail price of $342.23.
                                            package
                                            Package
                                            DosageQuantityPrice as low asPrice per unit
                                            28 tablets of 0.1mg/0.02mg/36.5mg1 package$271.83$271.83

                                            Typical dosing for Balcoltra

                                            Balcoltra comes in a 28-day pack, which contains 21 active (hormone) tablets and 7 placebo tablets. Each active tablet contains 0.1 mg levonorgestrel and 20 mcg ethinyl estradiol. Each placebo tablet contains 36.5 mg ferrous bisglycinate.

                                            Make sure to take your medication as instructed by your gynecologist or follow the directions on the package. In general, the typical dose is to take 1 active tablet by mouth daily for 21 days, followed by 1 placebo tablet daily for the remaining 7 days.

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                                            contraindications-icon

                                            Balcoltra contraindications

                                            Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Balcoltra will not be safe for you to take.
                                            alternatives

                                            What are alternatives to Balcoltra?

                                            There are a number of medications that your doctor can prescribe in place of Balcoltra. Compare a few possible alternatives below.
                                            Balcoltra
                                            Used for:
                                            $266.72 Lowest GoodRx priceView Prices
                                            Vienva
                                            Used for:

                                            • To prevent pregnancy

                                            $24.00 Lowest GoodRx priceView Prices
                                            Portia
                                            Used for:

                                            • To prevent pregnancy

                                            $22.99 Lowest GoodRx priceView Prices

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                                            References

                                            Best studies we found

                                            American College of Obstetricians and Gynecologists. (2023). Abnormal uterine bleeding.

                                            American College of Obstetricians and Gynecologists. (2023). Effectiveness of birth control methods.

                                            Avion Pharmaceuticals. (2022). Balcoltra- levonorgestrel and ethinyl estradiol [package insert]. DailyMed.

                                            View All References (14)

                                            Avion Pharmaceuticals. (2023). Balcoltra- levonorgestrel and ethinyl estradiol kit [package insert]. DailyMed.

                                            Centers for Disease Control and Prevention. (n.d.). Sexually transmitted infections (STIs).

                                            Centers for Disease Control and Prevention. (2024). About HIV.

                                            Centers for Disease Control and Prevention. (2024). Viral hepatitis among sexually active adults.

                                            Etminan, M., et al. (2011). Oral contraceptives and the risk of gallbladder disease: a comparative safety study. Canadian Medical Association Journal.

                                            Fischer, J. A. J., et al. (2021). Iron-containing oral contraceptives and their effect on hemoglobin and biomarkers of iron status: A narrative review. Nutrients.

                                            International Agency for Research on Cancer. (2012). Combined estrogen-progestogen contraceptives. Pharmaceuticals.

                                            Latwal, B., et al. (2020). Authorized generics vs. branded generics: A perspective. Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector.

                                            National Cancer Institute. (2018). Oral contraceptives and cancer risk.

                                            National Institute of Diabetes and Digestive and Kidney Disease. (2017). Gallstones.

                                            Rehak, M., et al. (2010). Retinal vein thrombosis: Pathogenesis and management. Journal of Thrombosis and Haemostasis.

                                            Xiromed, LLC. (2024). Joyeaux- levonorgestrel and ethinyl estradiol and ferrous fumarate [package insert]. DailyMed.

                                            Xiromed, LLC. (2024). Joyeaux- levonorgestrel and ethinyl estradiol and ferrous fumarate kit [package insert]. DailyMed.

                                            Xiromed LLC. (2023). Xiromed LLC announces launch of first-to-market generic version of Balcoltra® in the U.S.

                                            GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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