norgestimate / ethinyl estradiol

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

If you smoke cigarettes, using combined oral contraceptives (COCs) like Tri-Vylibra Lo raises your risk for serious health problems, such as strokes, heart attacks, and blood clots. Females aged 35 years and older who smoke are at even higher risk for these problems. If you smoke, talk with your healthcare professional 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 Tri-Vylibra Lo less than a month after childbirth | High blood pressure | People identified as obese | High cholesterol | Diabetes | Higher dose of estrogen

Tri-Vylibra Lo raises your risk of 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 healthcare professional you're taking Tri-Vylibra Lo. They might have you stop taking it 4 weeks before the surgery up until 2 weeks after your surgery to lower your risk of blood clots.

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

Study results are mixed, but there's a possibility that Tri-Vylibra Lo and other COCs can raise your risk for breast and cervical cancer.

Don't use Tri-Vylibra Lo if you have breast cancer because some types of breast cancer grow faster in the presence of estrogen, an ingredient in this birth control pill. To help with early breast cancer detection, you can do monthly breast self-checks at home and yearly breast exams with your healthcare professional. Call your HCP if you notice any abnormal changes or feel lumps, pain, or swelling in your breasts.

Get medical help right away if you experience abnormal vaginal bleeding, discharge, or pain during sex, since these could be signs of cervical cancer.

• Risk factors: Liver problems or infection in the liver | Taking COCs with 50 mcg of estrogen or higher

Though rare, Tri-Vylibra Lo can cause liver problems, such as liver damage and liver tumors. These problems are linked more with earlier formulations of COCs that contained higher levels of estrogen (50 mcg or higher), and less so with Tri-Vylibra Lo since it only contains 25 mcg of estrogen. Don't use this medication if you already have liver problems. Call your prescriber right away if you experience symptoms of liver problems, such as tiredness, stomach pain, or yellowing of the skin or whites of the eyes.

Some studies suggest that Tri-Vylibra Lo 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 Tri-Vylibra Lo.

• Risk factors: Pre-diabetes or diabetes | High triglycerides

Tri-Vylibra Lo can raise your levels of blood sugar and triglycerides (a type of fat). If you've been diagnosed with prediabetes or diabetes, your risk of having your blood sugar rise is much higher. This is because Tri-Vylibra Lo can prevent your body from breaking down sugar efficiently. Additionally, this medication can also affect your level of triglycerides. High triglycerides might lead to a higher risk of pancreatitis (pancreas inflammation). Speak with your prescriber before starting Tri-Vylibra Lo if you have a history of high blood sugar or triglycerides. They might help you choose another birth control or monitor your blood work more closely if you take this medication.

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

Tri-Vylibra Lo and other COCs can raise your blood pressure. Your prescriber might ask you to check your blood pressure regularly. If you notice your blood pressure is higher while you're taking this medication, contact your prescriber. If you have uncontrolled high blood pressure, Tri-Vylibra Lo might not be the best option for you.

Headaches are a common side effect of COCs like Tri-Vylibra Lo. But, if you experience a new migraine, a migraine that's worse than normal, or a new headache that keeps coming back or is severe, call your prescriber so you can be checked out.

Breakthrough bleeding and spotting are common side effects of hormonal birth control pills. This is more common during the first 3 months of using Tri-Vylibra Lo. Let your prescriber know if you experience any vaginal bleeding outside of your period, or if your period has stopped completely. There are other causes besides your birth control pills for irregular bleeding that your healthcare professional will evaluate.

• Risk factors: History of depression

Let your care team know if you experience symptoms of depression or worsening depression while taking Tri-Vylibra Lo. In cases of serious depression, your prescriber might have you stop taking it.

Certain medications can make Tri-Vylibra Lo get broken down faster in your body, making it work less well to prevent pregnancy. Some examples include carbamazepine (Tegretol) and phenytoin (Dilantin). Use a back-up method or other form of birth control for at least 28 days after stopping any of these medications. Other medications can raise the amount of Tri-Vylibra Lo in your body, which can lead to more side effects. Make sure to tell your prescriber or pharmacist all of your medications so they can make sure they don't interact with Tri-Vylibra Lo.

If you have hepatitis C and need to be treated with Viekira Pak (dasabuvir / ombitasvir / paritaprevir / ritonavir), immediately let your prescriber know that you're taking a COC. You'll need to stop Tri-Vylibra Lo before starting Viekira Pak because taking them together can cause liver problems. You can start Tri-Vylibra Lo again 2 weeks after you stop Viekira Pak.

• Risk factors: History of allergy to FD&C Yellow No. 5 (tartrazine)

Tri-Vylibra Lo and other generics might contain a dye called FD&C Yellow No. 5 (tartrazine). Although rare, some people can have an allergic reaction to this ingredient. If you have hives, itching, or other signs of an allergic reaction, seek medical attention.