MENOSTAR SIDE EFFECTS
- Generic Name: estradiol transdermal system
- Brand Name: Menostar
- Drug Class: Estrogen Derivatives
SIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders
- Malignant Neoplasms
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 | Menostar 14 mcg/day | Placebo |
| Adverse Reactions | (N=208) | (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 reactions.
SRC: NLM .