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Climara

Side Effects & Drug Interactions
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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)
0.025 mg/day
(N=219)		 0.05 mg/day
(N=201)		 0.1 mg/day
(N=194)
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: 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.

  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; hypocalcemia; exacerbation of asthma; increased triglycerides.

DRUG INTERACTIONS

Drug/Laboratory Test Interactions

  1. 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.
  2. 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.
  3. 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).
  4. Increased plasma HDL and HDL2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, and in oral formulations increased triglyceride levels.
  5. Impaired glucose tolerance.
  6. Reduced response to metyrapone test.
Brand Name: Climara
Generic Name: Estradiol Transdermal

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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