Women's Health / Gynecology

What is Oriahnn? Oriahnn is a brand-name prescription drug. It’s FDA-approved to reduce heavy menstrual bleeding caused by uterine fibroids (noncancerous tumors on the uterus). Oriahnn is used in adults who haven’t gone through menopause. Oriahnn should not be used for more than 24 months because of the risk of bone loss. (For more information on bone loss, refer to the “Oriahnn side effects” section below.) Drug details Oriahnn contains three active drugs: elagolix, estradiol, and norethindrone acetate. Elagolix belongs to a group of drugs called gonadotropin-releasing hormone (GnRH) antagonists. Estradiol is a type of estrogen hormone, and norethindrone acetate is a type of progestin hormone. Oriahnn lightens your periods by lowering the sex hormone levels in your body. Oriahnn comes as two separate capsules that you swallow. Each capsule is taken at a different time each day. The white and yellow capsule contains 300 milligrams (mg) of elagolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate. You’ll likely take the white and yellow capsule once per day in the morning. The white and blue capsule contains 300 mg of elagolix. You’ll likely take the white and blue capsule once per day in the evening. FDA approval In 2020, the Food and Drug Administration (FDA) approved Oriahnn to treat heavy menstrual bleeding related to uterine fibroids. Effectiveness To learn about the effectiveness of Oriahnn, refer to the “Oriahnn uses” section below. Oriahnn side effects Oriahnn can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Oriahnn. These lists don’t include all possible side effects. For more information about the possible side effects of Oriahnn, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome. Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Oriahnn, you can do so through MedWatch. Mild side effects Mild side effects of Oriahnn can include:* fatigue headache hot flashes† abnormal uterine bleeding,† such as spotting or bleeding between periods Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist. * This is a partial list of mild side effects from Oriahnn. To learn about other mild side effects, talk with your doctor or pharmacist, or visit Oriahnn’s prescribing information. † For more information about this side effect, refer to “Side effect details” below. Serious side effects Serious side effects from Oriahnn aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include: Gallbladder disease. Symptoms can include: dark-colored urine fever jaundice (yellowing of your skin or the whites of your eyes) loss of appetite nausea and vomiting sudden abdominal (belly) pain Hypertension (high blood pressure). This condition doesn’t usually cause any symptoms. High blood sugar. Symptoms can include: feeling more thirsty than usual urinating more often than usual High cholesterol. This condition doesn’t usually cause any symptoms. Liver problems. Symptoms can include: dark-colored urine fatigue jaundice nausea and vomiting upper-right abdominal pain Hair thinning or hair loss, which may or may not be reversible Allergic reaction.* Blood clots and blood vessel disorders,*† such as heart attack or stroke. Bone loss.* Mood changes, including suicidal thoughts and behaviors.* * For more information about these side effects, refer to “Side effect details” below. † Oriahnn has a boxed warningTrusted Source for this side effect. A boxed warning is the most serious warning from the FDA. For more information, refer to “Side effect details” below. Side effect details You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause. Allergic reaction As with most drugs, some people can have an allergic reaction after taking Oriahnn. Some people may have an allergic reaction to the drug itself. Other people may have a reaction to a certain ingredient in Oriahnn called yellow No. 5. (To learn more, refer to “Can I take Oriahnn if I’m allergic to food coloring, food dyes, or aspirin?” under “Common questions related to Oriahnn” below.) It isn’t known how many people in clinical trials had an allergic reaction to Oriahnn or yellow No. 5. Symptoms of a mild allergic reaction can include: skin rash itchiness flushing A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include: swelling under your skin, typically in your eyelids, lips, hands, or feet swelling of your tongue, mouth, or throat trouble breathing Call your doctor right away if you have an allergic reaction to Oriahnn, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency. Blood clots and blood vessel disorders In some people, taking Oriahnn can increase the risk of developing blood clots and blood vessel disorders, such as heart attack or stroke. Oriahnn has a boxed warningTrusted Source for this side effect. A boxed warning is the most serious warning from the FDA. Certain people may have a higher risk of developing blood clots or blood vessel disorders with Oriahnn. This includes people older than age 35 years who smoke. It also includes people who have obesity, diabetes, high cholesterol, or unmanaged hypertension (high blood pressure). Blood clots Taking Oriahnn can raise your risk for blood clots. Types of blood clots that could occur with Oriahnn include: deep vein thrombosis (DVT), a blood clot in a deep vein pulmonary embolism (PE), a blood clot in the lungs retinal vein thrombosis, a blood clot in the retina (a layer of tissue in the back of your eye) Symptoms of DVTs and PEs may include pain in your arm, chest, or leg, or swelling in your leg or arm. You could also experience trouble breathing or warmth in the affected area. Symptoms of a blood clot in the retina may include bulging eyes, double vision, migraine. Symptoms also include sudden vision changes in one eye, such as loss of vision or blurry vision. In clinical trials, adults were given either Oriahnn or a placebo (a treatment with no active drug) to treat their heavy menstrual bleeding. Of the people taking Oriahnn: 0.2% had a DVT after taking Oriahnn for 30 days 0.2% had a PE after taking Oriahnn for 8 months It isn’t known how many people who took a placebo had a DVT or PE. In addition, it isn’t known how many people had a blood clot in their retina after taking Oriahnn or a placebo. If you’re concerned about your risk for blood clots while taking Oriahnn, talk with your doctor. Heart attack Oriahnn treatment may increase the risk of a heart attack. The percentage of people who may have had a heart attack while taking Oriahnn in clinical trials isn’t known. Symptoms of a heart attack include a tightness, squeezing, pressure, or pain in your chest that may spread to your neck, back, or jaw. If you’re concerned about your risk for a heart attack during your Oriahnn treatment, talk with your doctor. Stroke Taking Oriahnn may raise the risk of a stroke. The percentage of people who may have had a stroke while taking Oriahnn in clinical trials isn’t known. Symptoms of a stroke include: severe headache trouble seeing, speaking, or walking weakness in one side of your face, one leg, or one arm If you’re concerned about your risk for a stroke while taking Oriahnn, talk with your doctor.