ELESTRIN SIDE EFFECTS
- Generic Name: estradiol gel
- Brand Name: Elestrin
- 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.
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 | ||
| 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) |
Postmarketing Experience
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.
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.
Breasts
Tenderness; enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
Cardiovascular
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
Gastrointestinal
Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.
Skin
Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
Eyes
Retinal vascular thrombosis, intolerance to contact lenses.
Central Nervous System
Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
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.
Additional postmarketing adverse reactions have been reported in women receiving other forms of hormone therapy.