norelgestromin / ethinyl estradiol

• Risk factors: Over 35 years old who smoke cigarettes

Smoking cigarettes while using Zafemy (norelgestromin / ethinyl estradiol) can significantly raise your risk for blood clots. These blood clots can lead to more serious problems, such as heart attack and stroke. The risk is greater if you're over 35 years old and have a history of smoking cigarettes. If you smoke, talk with your gynecologist about safer birth control alternatives.

• Risk factors: Age 35 or older and smoke | Recent surgery with a long period of bed rest | Starting Zafemy (norelgestromin / ethinyl estradiol) less than a month after childbirth | High blood pressure | People with BMI at or greater than 30 kg/m² | High cholesterol | Diabetes | Higher dose of estrogen

Compared to other combined hormonal contraceptives, Zafemy (norelgestromin / ethinyl estradiol) leads to higher estrogen absorption, which might raise the risk of side effects, including serious blood clots. These clots can occur anywhere in your body, including your lungs (pulmonary embolism or PE), legs (deep vein thrombosis or DVT), brain (stroke), and heart (heart attack). Get emergency help right away if you have any signs of a blood clot.

• Brain: weakness or numbness in your arms, legs, or face on one side of the body, trouble speaking, blurred vision, dizziness, loss of balance, trouble walking, or confusion
• Eyes: trouble seeing, bulging eye, double vision
• Heart: chest pain, sweating, nausea, or dizziness
• Lungs: trouble breathing, chest pain, or cough
• Legs: cramps, swelling, pain, or muscle tightness

If you need to have surgery, tell your care team you're taking Zafemy (norelgestromin / ethinyl estradiol). They might have you stop taking it 4 weeks before until 2 weeks after your surgery to lower your risk of blood clots. If you recently delivered a baby, you shouldn't start Zafemy (norelgestromin / ethinyl estradiol) until 4 weeks after delivery if you're not breastfeeding your child.

• Risk factors: Using hormonal contraceptives for more than 8 years

Don't use Zafemy (norelgestromin / ethinyl estradiol) if you have liver problems, such as hepatitis, severe cirrhosis, or liver tumors. Although rare, this medication can raise your risk of benign liver tumors. If you notice signs of liver problems, stop using Zafemy (norelgestromin / ethinyl estradiol) and talk to your gynecologist about other birth control options. Signs of liver problems include jaundice (yellowing of the skin or whites of the eyes), fever, tiredness, loss of appetite, or dark urine.

• Risk factors: Older age | Using hormonal contraceptives for a long time | History of high blood pressure

Zafemy (norelgestromin / ethinyl estradiol) can raise your blood pressure. The risk is higher if you're older and have been using birth control for a long time. If you have a history of high blood pressure that's well-controlled, your prescriber might monitor you while you use Zafemy (norelgestromin / ethinyl estradiol). If you have concerns, talk with them about the risks and benefits of using this medication.

• Risk factors: History of gallbladder problems

Some studies show that Zafemy (norelgestromin / ethinyl estradiol) can slightly raise your risk of gallbladder problems. And if you already have gallbladder problems, this medication could make them worse. If you’ve had cholestasis (a liver condition that slows or stops bile flow) from birth control or pregnancy before, you might have a higher risk of getting it again with Zafemy (norelgestromin / ethinyl estradiol). Talk to your prescriber if you have a history of gallbladder or liver problems before using this medication.

• Risk factors: Prediabetes or diabetes | High triglycerides

Zafemy (norelgestromin / ethinyl estradiol) can raise your blood sugar and triglycerides levels. If you have prediabetes or diabetes, your prescriber will likely monitor your blood sugar while you take this medication. High triglycerides can lead to a higher risk of pancreatitis (inflammation of the pancreas). Speak with your gynecologist before starting Zafemy (norelgestromin / ethinyl estradiol) if you have a history of high blood sugar or triglycerides. They might suggest a different birth control option or monitor your lab work more closely while you're using this medication.

Let your gynecologist know if you experience new or worsening migraines or headaches while using Zafemy (norelgestromin / ethinyl estradiol). If you develop frequent, severe, or new headaches, you might need to stop the medication.

People who use Zafemy (norelgestromin / ethinyl estradiol) can sometimes experience breakthrough bleeding or spotting. If this happens, talk to your gynecologist to rule out pregnancy, infections, or other medical conditions. If no serious cause is found, the bleeding might stop over time or after switching to a different birth control.

In clinical trials, most people started their withdrawal bleeding on the fourth day of the patch-free week, lasting about 5 to 6 days. If you have concerns about irregular bleeding, talk to your gynecologist.

• Risk factors: History of depression

If you have a history of depression, your prescriber will monitor you while using Zafemy (norelgestromin / ethinyl estradiol). If your depression gets worse or becomes serious, they might stop the medication. Let your prescriber know if you experience mood changes, sadness, or loss of interest in activities while taking this medication.

• Risk factors: History of breast or cervical cancer | Taking COCs for a long time

Study results are mixed, but Zafemy (norelgestromin / ethinyl estradiol) and other combined hormonal birth control pills might raise your risk for breast and cervical cancer.

Don't take Zafemy (norelgestromin / ethinyl estradiol) if you currently have or have had breast cancer because some types of breast cancer grow faster in the presence of estrogen, which is in this medication. Perform breast self-checks regularly at home and get yearly breast exams with your gynecologist to help with early detection. Let them know if you notice any new or abnormal lumps, pain, or swelling in your breasts.

Make sure you follow up with your gynecologist to get proper screenings for cervical cancer. Report any signs of vaginal bleeding or discharge that's not normal.

• Risk factors: History of hereditary angioedema | History of chloasma gravidarum

If you have certain conditions, such as hereditary angioedema or chloasma (a skin condition that causes dark patches on the face), talk to your prescriber before taking Zafemy (norelgestromin / ethinyl estradiol) because it might worsen your symptoms. If you have a history of chloasma, limit exposure to the sun or UV light while taking Zafemy (norelgestromin / ethinyl estradiol).