Menostar (Estradiol Transdermal) - Side Effects and Adverse Reactions

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 pai

Breast

Breast cancer, breast pain, breast tenderness

Cardiovascular

Changes in blood pressure, palpitations, hot flashe

Gastrointestinal

Vomiting, abdominal pain, abdominal distension, nause

Skin

Alopecia, hyperhidrosis, night sweats, urticaria, rash

Eyes

Visual disturbances, contact lens intoleranc

Central Nervous System

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

Miscellaneous

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