Oriahnn Side Effects
Generic name: elagolix / estradiol / norethindrone
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.
Important warnings
This medicine can cause some serious health issues
Oral route (capsule)
Thrombolic Disorders and Vascular Events. Estrogen 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.
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:
More common side effects
- feeling of warmth
- redness of the face, neck, arms, and occasionally, upper chest
Less common side effects
- 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
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:
Less common side effects
- 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
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
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
References
1. (2020) "Product Information. Oriahnn (elagolix / estradiol / norethindrone)." AbbVie US LLC
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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.