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Menostar (Estradiol Transdermal) - Side Effects and Adverse Reactions

Menostar Rx
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ADVERSE REACTIONS

See BOX 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.

Summary of Most Frequently Reported Treatment Emergent Adverse Experiences/Medical Events (>/=5%) By Treatment Groups
AE per Body System 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%)

The following additional adverse reactions have been reported with estrogens:

  1. 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; ovarian cancer; endometrial hyperplasia; endometrial cancer.
  2. Breasts
    Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
  3. Cardiovascular
    Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
  4. Gastrointestinal
    Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gall bladder disease; pancreatitis; enlargement of hepatic hemangiomas.
  5. Skin
    Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
  6. Eyes
    Retinal vascular thrombosis; intolerance to contact lenses.
  7. Central nervous system
    Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia.
  8. Miscellaneous
    Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; anaphylactoid/anaphylactic reactions including urticaria and angioedema; hypocalcemia; exacerbation of asthma; increased triglycerides.



REPORTS OF SUSPECTED MENOSTAR SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Menostar. The information is not vetted and should not be considered as verified clinical evidence.

Possible Menostar side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from United States on 2011-10-27

Patient: 60 year old female

Reactions: Hot Flush, Crying

Suspect drug(s):
Menostar


Possible Menostar side effects / adverse reactions in 50 year old female

Reported by a consumer/non-health professional from United States on 2012-01-19

Patient: 50 year old female

Reactions: Malabsorption, Blood Oestrogen Decreased

Suspect drug(s):
Menostar


Possible Menostar side effects / adverse reactions in 11 year old female

Reported by a pharmacist from United States on 2012-06-11

Patient: 11 year old female

Reactions: Skin Irritation, Application Site Irritation

Suspect drug(s):
Menostar


See index of all Menostar side effect reports >>
Drug label data at the top of this Page last updated: 2006-01-01

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