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Elagolix / estradiol / norethindrone Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 23, 2020.

For the Consumer

Applies to elagolix/estradiol/norethindrone: oral capsule

Warning

Oral route (Capsule)

Thrombolic Disorders and Vascular EventsEstrogen and progestin combinations, including elagolix, estradiol, and norethindrone acetate plus elagolix, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events.Elagolix, estradiol, and norethindrone acetate plus elagolix is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events including women over 35 years of age who smoke or women with uncontrolled hypertension.

Side effects requiring immediate medical attention

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:

Less common

  • Blurred vision
  • bone loss
  • chest pain
  • dark urine
  • discouragement
  • dizziness
  • feeling sad or empty
  • general feeling of tiredness or weakness
  • headache
  • irritability
  • lack of appetite
  • light-colored stools
  • longer or heavier menstrual periods
  • loss of interest or pleasure
  • mood swings
  • nervousness
  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected
  • pounding in the ears
  • slow or fast heartbeat
  • stomach pain
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the calf
  • thoughts or attempts at killing oneself
  • trouble concentrating
  • trouble sleeping
  • vomiting
  • yellow eyes or skin

Rare

  • Anxiety
  • cough
  • fainting
  • trouble with breathing

Side effects not requiring immediate medical attention

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:

More common

  • Feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest

Less common

  • Chills
  • decreased interest in sexual intercourse
  • diarrhea
  • difficulty in moving
  • fever
  • full or bloated feeling
  • general feeling of discomfort or illness
  • increased weight
  • joint pain
  • loss in sexual ability, desire, drive, or performance
  • muscle pain or stiffness
  • nausea
  • pressure in the stomach
  • runny nose
  • shivering
  • sore throat
  • sweating
  • swelling of the stomach area
  • thinning or loss of hair

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.