Oriahnn Side Effects
Generic name: elagolix / estradiol / norethindrone
Note: This document contains side effect information about elagolix / estradiol / norethindrone. Some of the dosage forms listed on this page may not apply to the brand name Oriahnn.
For the Consumer
Applies to elagolix/estradiol/norethindrone: oral capsule
Do not use this medicine if you are pregnant.
You should not use this medicine if you have: uncontrolled high blood pressure, heart disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease, severe migraine headaches, osteoporosis, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.
Taking this medicine can increase your risk of blood clots, stroke, or heart attack. Your risk of these side effects is highest if you are older than 35 and you smoke, or if you have high cholesterol, diabetes, uncontrolled high blood pressure, or if you are overweight.
Stop taking this medicine and seek medical attention right away if you have chest pain spreading to your jaw or shoulder, a sudden severe headache, problems with vision or speech, or swelling or pain in your leg.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Oriahnn may increase your risk of heart attack, stroke, or blood clot. Stop using this medicine and seek medical attention right away if you have:
chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
swelling, pain, warmth, or redness in an arm or leg;
sudden shortness of breath;
sudden numbness, weakness, or severe headache;
vision problems, bulging eyes; or
Call your doctor at once if you have:
high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
liver or gallbladder problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, bruising, swelling, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
This medicine may cause hair loss that may be permanent.
Common side effects may include:
hair loss (may be permanent);
irregular menstrual periods.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to elagolix / estradiol / norethindrone: oral capsule
The more commonly reported adverse reactions have included hot flush, headache, fatigue, and metrorrhagia.[Ref]
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]
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]
Very common (10% or more): Loss of bone mineral density (BMD) in lumbar spine (27%)
Common (1% to 10%): Arthralgia[Ref]
Common (1% to 10%): Increased weight
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]
Common (1% to 10%): Decreased libido; adverse mood changes including depression, depressed mood, tearfulness
Frequency not reported: Suicide[Ref]
Common (1% to 10%): Metrorrhagia[Ref]
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]
Uncommon (0.1% to 1%): Breast Cancer[Ref]
Common (1% to 10%): Headache[Ref]
Common (1% to 10%): Fatigue[Ref]
Common (1% to 10%): Influenza
1. "Product Information. Oriahnn (elagolix / estradiol / norethindrone)." AbbVie US LLC, North Chicago, IL.
More about Oriahnn (elagolix / estradiol / norethindrone)
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: sex hormone combinations
- FDA Approval History
Related treatment guides
Some side effects may not be reported. You may report them to the FDA.