Oriahnn Side Effects

Generic name: elagolix / estradiol / norethindrone

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 15, 2024.

Note: This document provides detailed information about Oriahnn Side Effects associated with elagolix / estradiol / norethindrone. Some dosage forms listed on this page may not apply specifically to the brand name Oriahnn.

Applies to elagolix / estradiol / norethindrone: oral capsule.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) during treatment and for at least 28 days after the last dose. If a pregnancy occurs while using the medicine, tell your doctor right away.

Do not use this medicine together with medicines called OATP 1B1 inhibitors that may increase elagolix levels in the blood. Your doctor should give you a list of these medicines.

Do not use this medicine if you smoke cigarettes or if you are over 35 years old. If you smoke while using this medicine, you increase your risk of having a heart attack, stroke, or blood clot. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty with breathing, a sudden, severe headache, slurred speech, a sudden, a sudden loss of coordination, or vision changes while using this medicine.

This medicine can cause your bone mineral density to decrease, which may lead to osteoporosis or weakened bones. Check with your doctor if you have pain in the back, ribs, arms, or legs, or a decrease in your height.

This medicine may increase your risk of having hormone-sensitive cancer, including breast cancer. Check with your doctor right away if you have clear or bloody discharge from the nipple, an inverted nipple, dimpling of the breast skin, a lump in the breast or under the arm, crusting or scaling of the nipple, redness or swelling of the breast, or a sore on the skin of the breast that does not heal.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause changes in menstrual bleeding, which may decrease your ability to recognize pregnancy. Talk to your doctor if you have concerns.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine for at least 4 to 6 weeks before having surgery.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Oriahnn

Some side effects of elagolix / estradiol / norethindrone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects of Oriahnn

Along with its needed effects, elagolix/estradiol/norethindrone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking elagolix / estradiol / norethindrone:

For healthcare professionals

Applies to elagolix / estradiol / norethindrone: oral capsule.

General adverse events

The more commonly reported adverse reactions have included hot flush, headache, fatigue, and metrorrhagia.^[Ref]

Cardiovascular

• Very common (10% or more): Hot flush (22%)
• Common (1% to 10%): Hypertension
• Uncommon (0.1% to 1%): Thrombotic events^[Ref]

During clinical trials, 2 thrombotic events were reported (n=453). A woman with obesity developed thrombosis in her left calf after 30 days of treatment. A second woman developed a pulmonary embolism 8 months into treatment.

During clinical trials, maximum mean increases in systolic and diastolic blood pressure were 5.1 and 2.1 mmHg, respectively occurring at month 5 and month 4, respectively.^[Ref]

Musculoskeletal

• Very common (10% or more): Loss of bone mineral density (BMD) in lumbar spine (27%)
• Common (1% to 10%): Arthralgia^[Ref]

During clinical trials, BMD was assessed by dual-energy X-ray absorptiometry (DXA). At 6 months, the percent change in lumbar spine BMD was -0.7% in women receiving this drug compared with -0.1% for placebo. For women treated with this drug for 12 months, 27% experienced a decline in lumbar spine BMD of greater than 3%; 1.7% experienced a decline of 8% or greater. Following cessation of therapy, continued bone loss was observed at the lumbar spine, total hip, and femoral neck in 24%, 32%, and 40% of women, respectively; partial recovery occurred in 46%, 33%, and 38% and full recovery was observed in 30%, 35%, and 22% at these same sites.^[Ref]

Metabolic

• Common (1% to 10%): Increased weight

Psychiatric

• Common (1% to 10%): Decreased libido; adverse mood changes including depression, depressed mood, tearfulness

Elagolix:

• Frequency not reported: Suicide^[Ref]

During clinical trials, depression, depressed mood, and/or tearfulness were reported in 3% of women receiving this drug compared to 1% of placebo-treated women. In clinical trials for elagolix, a woman treated with lower dose elagolix alone completed suicide 2 days after elagolix discontinuation.^[Ref]

Genitourinary

• Common (1% to 10%): Metrorrhagia^[Ref]

Dermatologic

• Common (1% to 10%): Alopecia^[Ref]

Hepatic

• Common (1% to 10%): Transaminase elevations^[Ref]

During clinical trials, ALT and AST elevations of up to 3 times the upper limit of normal (3 x ULN) occurred in 1.1% and 1.3% of women treated with this drug, respectively compared with 0% receiving placebo. Peak elevation in AST of almost 8 x ULN and ALT of 6 x ULN was reported.^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Breast Cancer^[Ref]

In phase 3 trials, 2 cases of breast cancer were reported among 453 women receiving this drug.^[Ref]

Nervous system

• Common (1% to 10%): Headache^[Ref]

Other

• Common (1% to 10%): Fatigue^[Ref]

Gastrointestinal

• Common (1% to 10%): Abdominal distension, vomiting^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory tract infection^[Ref]

Immunologic

• Common (1% to 10%): Influenza

See also:

Further information

Oriahnn side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer