Myfembree Side Effects

Generic name: estradiol / norethindrone / relugolix

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 18, 2024.

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

Applies to estradiol / norethindrone / relugolix: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Estrogen and progestin combination products, including relugolix/estradiol/norethindrone acetate, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism (PE), deep vein thrombosis (DVT), stroke and myocardial infarction (MI), especially in women at increased risk for these events.

Relugolix/estradiol/norethindrone acetate 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.

Serious side effects of Myfembree

Along with its needed effects, estradiol / norethindrone / relugolix 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 estradiol / norethindrone / relugolix:

More common side effects

• heavy non-menstrual vaginal bleeding
• longer or heavier menstrual periods
• normal menstrual bleeding occurring earlier, possibly lasting longer than expected
• unusually heavy or unexpected menstrual bleeding
• vaginal bleeding or spotting

Less common side effects

• anxiety
• discouragement
• feeling sad or empty
• hair loss, thinning of hair
• irritability
• lack of appetite
• loss of interest or pleasure
• mood swings
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness

Rare side effects

• pelvic pain
• stomach pain, bloating

Incidence not known

• blurred vision
• chest pain or tightness
• chills
• clay-colored stools
• cough
• dark urine
• diarrhea
• dizziness or lightheadedness
• dry mouth
• fainting
• fast heartbeat
• fever
• fruit-like breath odor
• headache
• hives, itching
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of consciousness
• nausea and vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• trouble breathing
• unexplained weight loss
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Other side effects of Myfembree

Some side effects of estradiol / norethindrone / relugolix 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
• increased sweating
• night sweats
• redness of the face, neck, arms, and occasionally, upper chest
• toothache

Less common side effects

• back pain
• decreased interest in sexual intercourse
• difficulty in moving
• inability to have or keep an erection
• joint pain
• loss in sexual ability, desire, drive, or performance
• muscle pain or stiffness

For healthcare professionals

Applies to estradiol / norethindrone / relugolix: oral tablet.

General adverse events

In women with heavy menstrual bleeding associated with uterine fibroids, the most common adverse reactions occurring in 3% of patients or greater included vasomotor symptoms, uterine bleeding, alopecia, and decreased libido. Serious adverse reactions occurring in up to 3% of patients included uterine myoma expulsion and menorrhagia, uterine leiomyoma (prolapse), cholecystitis, and pelvic pain.

In women with moderate to severe pain associated with endometriosis, the most common adverse reactions occurring in 3% of patients or greater included headache, vasomotor symptoms, mood disorders, abnormal uterine bleeding, nausea, toothache, back pain, decreased sexual desire and arousal, arthralgia, fatigue, and dizziness. Serious adverse reactions occurring in up to 3% of patients included uterine hemorrhage, suicidal ideation, cholelithiasis, and cholecystitis.^[Ref]

Cardiovascular

• Common (1% to 10%): Hot flush, new/worsening hypertension
• Rare (0.01% to 0.1%): Thromboembolic events (deep vein thrombosis [DVT], pulmonary embolism [PE])

Postmarketing reports for relugolix monotherapy: Thromboembolic events^[Ref]

Dermatologic

• Common (1% to 10%): Alopecia/hair loss/hair thinning, hyperhidrosis, night sweats
• Uncommon (0.1% to 1%): Angioedema, urticaria

Postmarketing reports, including relugolix monotherapy: Drug eruption^[Ref]

Gastrointestinal

• Common (1% to 10%): Dyspepsia, nausea, toothache, diarrhea^[Ref]

Genitourinary

• Very common (10% or more): Resumption of menstruation after drug discontinuation (up to 100%), amenorrhea (up to 71%), irregular bleeding pattern (32%), cyclic bleeding (15%)
• Common (1% to 10%): Abnormal uterine bleeding (menorrhagia, metrorrhagia, vaginal hemorrhage, uterine hemorrhage, polymenorrhea, and menstruation irregular), vulvovaginal dryness
• Uncommon (0.1% to 1%): Uterine myoma expulsion, uterine leiomyoma (prolapse), pelvic pain

Postmarketing reports, including relugolix monotherapy: Uterine leiomyoma degeneration^[Ref]

Hepatic

• Uncommon (less than 1%): Elevated AST and/or ALT greater than 3 times the upper limit of normal
• Frequency not reported: Gallbladder disease, cholelithiasis and cholecystitis^[Ref]

Hypersensitivity

• Postmarketing reports: Anaphylactoid reaction^[Ref]

Musculoskeletal

• Very common (10% or more): Decline in lumbar spine bone mineral density (up to 23%)
• Common (1% to 10%): Back pain, arthralgia, bone loss
• Uncommon (0.1% to 1%): Low trauma fractures^[Ref]

In some women who had normal bone mineral density (BMD) at start of treatment with this drug, a bone loss varying from greater than 3 to 8% was reported.^[Ref]

Nervous system

• Very common (10% or more): Headache (33%)

Other

• Very common (10% or more): Decreased high-density lipoprotein (HDL) cholesterol (up to 22.2%), vasomotor symptoms including hot flush, hyperhidrosis, night sweats, and flushing (up to 13%), increased total cholesterol (up to 13.7%)
• Common (1% to 10%): Increased low-density lipoprotein (LDL) cholesterol, breast cyst, fatigue, peripheral edema^[Ref]

Psychiatric

• Common (1% to 10%): Decreased sexual desire and arousal (libido decreased, libido disorder, loss of libido, female sexual arousal disorder), mood disorders (affect lability, affective disorder, anxiety, depressed mood, mood swings, depression, emotional distress, generalized anxiety disorder, irritability, mixed anxiety and depressive disorder, mood altered, mood swings, suicidal ideation)^[Ref]

Respiratory

• Frequency not reported: Pulmonary embolism^[Ref]

Frequently asked questions

• Does Myfembree shrink fibroids?

Further information

Myfembree 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