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Prefest

"Oct. 24, 2012 -- Women who take hormones within five years of menopause may have a slightly lower risk of Alzheimer's disease compared to women who don't ever take them, a new study shows.

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Prefest

Prefest

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.

Table 7. ALL TREATMENT-EMERGENT ADVERSE EVENTS REGARDLESS OF DRUG RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5% WITH PREFEST (estradiol, norgestimate)

FOUR 12-MONTH CLINICAL TRIALS
  PREFEST (estradiol, norgestimate) (Estradiol and NGM)
(N = 579)
N (%)
Body as a Whole
  Back pain 69 (12%)
  Fatigue 32 ( 6%)
  Influenza-like symptoms 64 (11%)
  Pain 37 ( 6%)
Digestive System
  Abdominal pain 70 (12%)
  Flatulence< 29 ( 5%)
  Nausea 34 ( 6%)
  Tooth disorder 27 ( 5%)
Musculoskeletal System
  Arthralgia 51 ( 9%)
  Myalgia 30 ( 5%)
Nervous System
  Dizziness 27 (5%)
  Headache 132 (23%)
Psychiatric Disorders
  Depression 27 (5%)
Reproductive System
  Breast pain 92 (16%)
  Dysmenorrhea 48 ( 8%)
  Vaginal bleeding (all) 52 ( 9%)
  Vaginitis 42 ( 7%)
Resistance Mechanism Disorders
  Viral infection 35 ( 6%)
Respiratory System
  Coughing 28 ( 5%)
  Pharyngitis 38 ( 7%)
  Sinusitis 44 ( 8%)
  Upper respiratory-tract infection 121 (21%)

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 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; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

Read the Prefest (estradiol, norgestimate) Side Effects Center for a complete guide to possible side effects

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-1-antitrypsin, ceruloplasmin).
  4. Increased plasma HDL and HDL2cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels.
  5. Impaired glucose tolerance.
  6. Reduced response to metyrapone test.

Read the Prefest Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 3/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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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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