levonorgestrel / ethinyl estradiol / ferrous bisglycinate

• 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 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 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 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.

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 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 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.

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 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.

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.