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The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Malignant Neoplasms [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
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
|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%)|
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.
Changes in bleeding pattern, pelvic pain
Vomiting, abdominal pain, abdominal distension, nausea
Visual disturbances, contact lens intolerance
Central Nervous System
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
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
Additional Menostar Information
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