The following serious adverse reactions are discussed elsewhere in the labeling:
Cardiovascular Disorders [see BOXED WARNING, and WARNINGS AND PRECAUTIONS]
Malignant Neoplasms [see BOXED WARNING, and 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.
ELESTRIN was studied in a placebo-controlled trial that included a total of 484 postmenopausal women. The adverse reactions that occurred at a rate greater than 5 percent in any of the treatment groups are summarized in Table 1.
TABLE 1 :Incidence of Treatment-Emergent Adverse Reactions Occurring in ≥ 5 Percent of Subjects
|Body System / Signs and Symptoms||Number (%) of Subjects|
(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 adverse reactions have been identified during post-approval use of ELESTRIN. 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 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.
Tenderness; enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.
Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous System
Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
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.
Additional postmarketing adverse reactions have been reported in women receiving other forms of hormone therapy.