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Elestrin (Estradiol Transdermal) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

See BOXED 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.

Elestrin® was studied in a placebo-controlled trial that included a total of 484 postmenopausal women. The adverse events that occurred at a rate greater than 5% in any of the treatment groups are summarized in Table 5.

TABLE 5 - Incidence of Treatment-Emergent Adverse Events Occurring in ≥ 5% of Subjects
Body System / Signs and Symptoms Number (%) of Subjects
Placebo
(n = 137)
Elestrin® 0.87 g/day
(n = 136)
Elestrin® 1.7 g/day
(n = 142)
Reproductive system & breast disorders      
  Breast tenderness 5 (3.6) 9 (6.6) 11 (7.7)
  Metrorrhagia 3 (2.2) 6 (4.4) 13 (9.2)
Respiratory, thoracic & mediastinal disorders      
  Nasopharyngitis 10 (7.3) 14 (10.3) 12 (8.5)
  Upper respiratory tract infection 5 (3.6) 8 (5.9) 5 (3.5)

The following additional adverse reactions have been reported with estrogen and/or progestin therapy.

  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 gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.
  5. Skin
    Chloasma or melasma that 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; arthralgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.


REPORTS OF SUSPECTED ELESTRIN SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Elestrin side effects / adverse reactions in 9 month old female

Reported by a pharmacist from United States on 2011-11-21

Patient: 9 month old female

Reactions: Precocious Puberty, Accidental Exposure, FAT Tissue Increased

Suspect drug(s):
Elestrin



Possible Elestrin side effects / adverse reactions in 52 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-20

Patient: 52 year old female weighing 59.0 kg (129.8 pounds)

Reactions: Oestradiol Increased, Oestrone Increased

Suspect drug(s):
Elestrin

Other drugs received by patient: Progesterone



Possible Elestrin side effects / adverse reactions in 49 year old female

Reported by a consumer/non-health professional from United States on 2012-07-03

Patient: 49 year old female

Reactions: Hot Flush, Thermal Burn

Suspect drug(s):
Elestrin



See index of all Elestrin side effect reports >>

Drug label data at the top of this Page last updated: 2012-06-29

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