April 29, 2017
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Menostar

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Menostar




Side Effects
Interactions

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trials Experience

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.

Menostar was investigated in a 2-year double blind, placebo-controlled, multicenter study in the United States. A total of 417 postmenopausal women (208 women on Menostar, 209 on placebo) 60 to 80 years old, with an intact uterus were enrolled in the study. At 24 months, 189 women remained in the Menostar group and 186 remained in the placebo group. Adverse events with an incidence of ≥ 5 percent in the Menostar 14 mcg group and greater than those reported in the placebo group are listed in Table 1.

Table 1: Summary of Most Frequently Reported Treatment Emergent Adverse Reactions ( ≥ 5 percent) by Treatment Groups

Body System Adverse Reactions Menostar 14 mcg/day
(N=208)
Placebo
(N=209)
Body as a Whole 95 (46%) 100 (48%)
  Abdominal Pain 17 (8%) 17 (8%)
  Accidental Injury 29 (14%) 23 (11%)
  Infection 11 (5%) 10 (5%)
  Pain 26 (13%) 26 (12%)
Cardiovascular 20 (10%) 19 (9%)
Digestive System 52 (25%) 44 (21%)
  Constipation 11 (5%) 6 (3%)
  Dyspepsia 11 (5%) 9 (4%)
Metabolic and Nutritional Disorders 25 (12%) 22 (11%)
Musculoskeletal System 54 (26%) 51 (24%)
  Arthralgia 24 (12%) 13 (6%)
  Arthritis 11 (5%) 15 (7%)
  Myalgia 10 (5%) 6 (3%)
Nervous System 30 (14%) 23 (11%)
  Dizziness 11 (5%) 6 (3%)
Respiratory System 62 (30%) 67 (32%)
  Bronchitis 12 (6%) 9 (4%)
  Upper Respiratory Infection 33 (16%) 35 (17%)
Skin and Appendages 50 (24%) 54 (26%)
  Application Site Reaction 18 (9%) 18 (9%)
  Breast Pain 10 (5%) 8 (4%)
Urogenital System 66 (32%) 40 (19%)
  Cervical Polyps 13 (6%) 4 (2%)
  Leukorrhea 22 (11%) 3 (1%)

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of the Climara transdermal system and the Menostar transdermal system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary System

Changes in bleeding pattern, pelvic pain

Breast

Breast cancer, breast pain, breast tenderness

Cardiovascular

Changes in blood pressure, palpitations, hot flashes

Gastrointestinal

Vomiting, abdominal pain, abdominal distension, nausea

Skin

Alopecia, hyperhidrosis, night sweats, urticaria, rash

Eyes

Visual disturbances, contact lens intolerance

Central Nervous System

Depression, migraine, paresthesia, dizziness, anxiety, irritability, mood swings, nervousness, insomnia, headache

Miscellaneous

Edema, fatigue, menopausal symptoms, weight increased, application site reaction, anaphylactic reaction

Read the Menostar (estradiol transdermal system) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Metabolic Interactions

In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's wort (hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/28/2016

Side Effects
Interactions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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