Climara (Estradiol Transdermal) Drug Information: Side Effects and Drug Interactions

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May 26, 2012

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Menopause is defined as the state of an absence of menstrual periods for 12 months. The menopausal transition starts with varying menstrual cycle length and ends with the final menstrual period. Perimenopause means "the time around menopause" and is often used to refer to the menopausal transitional period. It is not officially a medical term, but is sometimes used to explain certain aspects of the menopause transition in lay terms. Postmenopause is the entire period of time that comes after the last menstrual period.

Menopause is the time in a woman's life when the function of the ovaries ceases. The ovary (female gonad), is one of a pair of reproductive glands in women. They are located in the pelvis, one on each side of the uterus. Each ovary is about the size and shape of an almond. The ovaries produce eggs (ova) and female hormones such as estrogen. During each monthly menstrual cycle, an egg is released f...

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SIDE EFFECTS

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.

Summary of Most Frequently Reported Adverse Experiences/Medical Events ( ≥ 5%) by Treatment Groups

AE per Body System	Climara			Placebo (N=72)
AE per Body System	0.025 mg/day (N=219)	0.05 mg/day (N=201)	0.1 mg/day (N=194)	Placebo (N=72)
Body as a Whole	21%	39%	37%	29%
Headache	5%	18%	13%	10%
Pain	1%	8%	11%	7%
Back Pain	4%	8%	9%	6%
Edema	0.5%	13%	10%	6%
Gastro-Intestinal	9%	21%	29%	18%
Abdominal Pain	0%	11%	16%	8%
Nausea	1%	5%	6%	3%
Flatulence	1%	3%	7%	1%
Musculo-Skeletal	7%	9%	11%	4%
Arthralgia	1%	5%	5%	3%
Psychiatric	13%	10%	11%	1%
Depression	1%	5%	8%	0%
Reproductive	12%	18%	41%	11%
Breast Pain	5%	8%	29%	4%
Leukorrhea	1%	6%	7%	1%
Respiratory	15%	26%	29%	14%
URTI	6%	17%	17%	8%
Pharyngitis	0.5%	3%	7%	3%
Sinusitis	4%	4%	5%	3%
Rhinitis	2%	4%	6%	1%
Skin and Appendages	19%	12%	12%	15%
Pruritus	0.5%	6%	3%	6%

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Climara (estradiol transdermal) : a few cases in which there were a combination of the symptoms of generalized hives or rash with swelling of the throat or eyelid edema. 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.

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

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 gall bladder disease; pancreatitis; enlargement of hepatic hemangiomas.
Skin
Chloasma or melasma, which 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; arthalgias; leg cramps; changes in libido; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

DRUG INTERACTIONS

Drug/Laboratory Test Interactions

Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T₄ levels (by column or by radioimmunoassay) or T₃ levels by radioimmunoassay. T₃ resin uptake is decreased, reflecting the elevated TBG. Free T₄ and free T₃ concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
Other binding proteins may be elevated in serum (i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG)) leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-l-antitrypsin, ceruloplasmin).
Increased plasma HDL and HDL₂ cholesterol subfraction concentrations, reduced LDL cholesterol concentration, and in oral formulations increased triglyceride levels.
Impaired glucose tolerance.
Reduced response to metyrapone test.