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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

Warning

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

  • trouble speaking.

Call your doctor at once if you have:

  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

  • any new or worsening mood symptoms--mood or behavior changes, depression, anxiety, thoughts about suicide or hurting yourself; or

  • 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:

  • hot flashes;

  • feeling tired;

  • hair loss (may be permanent);

  • headache; or

  • 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

General

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

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]

Metabolic

Common (1% to 10%): Increased weight

Psychiatric

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

Elagolix:

Frequency not reported: Suicide[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

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

Uncommon (0.1% to 1%): Breast Cancer[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

References

1. "Product Information. Oriahnn (elagolix / estradiol / norethindrone)." AbbVie US LLC, North Chicago, IL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.