Mimvey

Mimvey Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Mimvey (estradiol and norethindrone acetate) is a combination of female hormones used in women who have a uterus to treat moderate to severe vasomotor symptoms associated with menopause, and to prevent postmenopausal osteoporosis. Common side effects include headache, irregular vaginal bleeding or spotting, nausea and vomiting, back pain, hair loss, breast pain, stomach/abdominal cramps, bloating, depression, and weight gain.

Mimvey therapy consists of a single tablet to be taken once daily. Mimvey may interact with other drugs. Tell your doctor all medications and supplements you use. Mimvey is not recommended for use during pregnancy. It may cause birth defects. This drug passes into breast milk and may affect the quality and quantity of milk produced. Consult your doctor before breastfeeding.

Our Mimvey (estradiol and norethindrone acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Mimvey FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

See BOXED WARNINGS, WARNINGS and PRECAUTIONS.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Adverse events reported with estradiol and norethindrone acetate 1 mg/0.5 mg by investigators in the Phase 3 studies regardless of causality assessment are shown in Table 6.

TABLE 6 : ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5% WITH ESTRADIOL AND NORETHINDRONE ACETATE 1 MG/0.5 MG

  Endometrial
Hyperplasia Study
(12-Months)
Vasomotor
Symptoms Study
(3-Months)
Osteoporosis Study (2-Years)
Estradiol and Norethindrone Acetate 1 mg/0 .5 mg
(n=295)
1 mg E2
(n=296)
Estradiol and Norethindrone Acetate 1 mg /0.5 mg
(n=29)
Placebo
(n=34)
Estradiol and Norethindrone Acetate 1 mg/0 .5 mg
(n=47)
Placebo
(n=48)
Body as a Whole
Back Pain 6% 5% 3% 3% 6% 4%
Headache 16% 16% 17% 18% 11% 6%
Digestive System
Nausea 3% 5% 10% 0% 11% 0%
Gastroenteritis 2% 2% 0% 0% 6% 4%
Nervous System
Insomnia 6% 4% 3% 3% 0% 8%
Emotional Lability 1% 1% 0% 0% 6% 0%
Respiratory System
Upper Respiratory Tract Infection 18% 15% 10% 6% 15% 19%
Sinusitis 7% 11% 7% 0% 15% 10%
Metabolic and Nutritional
Weight Increase 0% 0% 0% 0% 9% 6%
Urogenital System
Breast Pain 24% 10% 21% 0% 17% 8%
Post- Menopausal Bleeding 5% 15% 10% 3% 11% 0%
Uterine 5% 4% 0% 0% 4% 8%
Fibroid
Ovarian Cyst 3% 2% 7% 0% 0% 8%
Resistance Mechanism
Infection Viral 4% 6% 0% 3% 6% 6%
Moniliasis Genital 4% 7% 0% 0% 6% 0%
Secondary Terms
Injury Accidental 4% 3% 3% 0% 17%* 4%*
Other Events 2% 3% 3% 0% 6% 4%
*including one upper extremity fracture in each group

Adverse events reported with estradiol and norethindrone acetate 0.5 mg/0.1 mg by investigators during the Phase 3 study regardless of causality assessment are shown in Table 7.

TABLE 7 : ALL TREATMENT-ADVERSE EVENTS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5% WITH ESTRADIOL AND NORETHINDRONE ACETATE 0.5 MG/0.1 MGG

  Estradiol and Norethindrone Acetate 0 .5 mg /0.1 mg
(n=194)
Placebo
(n=200)
Body as a Whole
Back Pain 10% 4%
Headache 22% 19%
Pain in extremity 5% 4%
Digestive System
Nausea 5% 4%
Diarrhea 6% 6%
Respiratory System
Nasopharyngitis 21% 18%
Urogenital System
Endometrial thickening 10% 4%
Vaginal hemorrhage 26% 12%

The following adverse reactions have been reported with estrogen and/or progestin therapy:

Genitourinary System

Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; premenstrual-like syndrome; cystitis-like syndrome; ovarian cancer; endometrial hyperplasia; endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.

Cardiovascular

Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction, stroke; increase in blood pressure.

Gastrointestinal

Nausea, vomiting; changes in appetite; cholestatic jaundice; abdominal pain/cramps, flatulence, bloating; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.

Skin

Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; seborrhea; hirsutism; itching; skin rash; pruritus.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

Headache; migraine; dizziness; mental depression; chorea; insomnia; nervousness; mood disturbances; irritability; exacerbation of epilepsy; probable dementia.

Miscellaneous

Increase or decrease in weight; aggravation of porphyria; edema; leg cramps; changes in libido; fatigue; reduced carbohydrate tolerance; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; back pain; arthralgia; myalgia.

Read the entire FDA prescribing information for Mimvey (Estradiol and Norethindrone Acetate Tablets) »

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