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Vivelle-Dot

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Vivelle-Dot

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.

The following adverse events have been reported with Vivelle-Dot® (estradiol transdermal system) (estradiol transdermal system) therapy:

Table 3: Summary of Most Frequently Reported Adverse Experiences/Medical Events Regardless of Relationship Reported at a Frequency ≥5%

  Vivelle
0.025 mg/day†
(N=47)
N (%)
Vivelle 0.0375
mg/day†
(N=130)
N (%)
Vivelle 0.05
mg/day†
(N=103)
N (%)
Vivelle
0.075 mg/day†
(N=46)
N (%)
Vivelle
0.1 mg/day†
(N=132)
N (%)
Placebo
(N=157)
N (%)
Gastrointestinaldis orders
Constipation 2 (4.3) 5 (3.8) 4 (3.9) 3 (6.5) 2 (1.5) 4 (2.5)
Dyspepsia 4 (8.5) 12 (9.2) 3 (2.9) 2 (4.3) 0 10 (6.4)
Nausea 2 (4.3) 8 (6.2) 4 (3.9) 0 7 (5.3) 5 (3.2)
General disorders and administration site conditions***
Influenza like illness 3 (6.4) 6 (4.6) 8 (7.8) 0 3 (2.3) 10 (6.4)
Pain NOS* 0 8 (6.2) 0 2 (4.3) 7 (5.3) 7 (4.5)
Infections and infestations
Influenza 4 (8.5) 4 (3.1) 6 (5.8) 0 10 (7.6) 14 (8.9)
Nasopharyngitis 3 (6.4) 16 (12.3) 10 (9.7) 9 (19.6) 11 (8.3) 24 (15.3)
Sinusitis NOS* 4 (8.5) 17 (13.1) 13 (12.6) 3 (6.5) 7 (5.3) 16 (10.2)
Upper respiratory tract infection NOS* 3 (6.4) 8 (6.2) 11 (10.7) 4 (8.7) 6 (4.5) 9 (5.7)
Investigations
Weight increased 4 (8.5) 5 (3.8) 2 (1.9) 2 (4.3) 0 3 (1.9)
Musculoskeletal andconnective tissue disorders
Arthralgia 0 11 (8.5) 4 (3.9) 2 (4.3) 5 (3.8) 9 (5.7)
Back pain 4 (8.5) 10 (7.7) 9 (8.7) 4 (8.7) 14 (10.6) 10 (6.4)
Neck pain 3 (6.4) 4 (3.1) 4 (3.9) 0 6 (4.5) 2 (1.3)
Pain in limb 0 10 (7.7) 7 (6.8) 2 (4.3) 6 (4.5) 9 (5.7)
Nervous system disorders
Headache NOS* 7 (14.9) 35 (26.9) 32 (31.1) 23 (50.0) 34 (25.8) 37 (23.6)
Sinus headache 0 12 (9.2) 5 (4.9) 5 (10.9) 2 (1.5) 8 (5.1)
Psychiatric disorders
Anxiety NEC** 3 (6.4) 5 (3.8) 0 0 2 (1.5) 4 (2.5)
Depression 5 (10.6) 4 (3.1) 7 (6.8) 0 4 (3.0) 6 (3.8)
Insomnia 3 (6.4) 6 (4.6) 4 (3.9) 2 (4.3) 2 (1.5) 9 (5.7)
Reproductive system and breast disorders
Breast tenderness 8 (17.0) 10 (7.7) 8 (7.8) 3 (6.5) 17 (12.9)0  
Dysmenorrhea 0 0 0 3 (6.5) 0 0
Intermenstrual bleeding 3 (6.4) 9 (6.9) 6 (5.8) 0 14 (10.6) 7 (4.5)
Respiratory, thoracic and mediastinal disorders
Sinus congestion 0 4 (3.1) 3 (2.9) 3 (6.5) 6 (4.5) 7 (4.5)
Vascular disorders
Hot flushes NOS* 3 (6.4) 0 3 (2.9) 0 0 6 (3.8)
Hypertension NOS* 2 (4.3) 0 3 (2.9) 0 0 2 (1.3)
Represents milligrams of estradiol delivered daily by each system
* NOS represents not otherwise specified
** NEC represents not elsewhere classified
*** Application site erythema and application site irritation were observed in a small number of patients (3.2% or less of patients across treatment groups.)

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 gallbladder 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; steepening of corneal curvature; 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; arthralgias; leg cramps; changes in libido; anaphylactoid/anaphylactic reactions including urticaria and angioedema; hypocalcemia; exacerbation of asthma; increased triglycerides.

Read the Vivelle-Dot (estradiol transdermal system) 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 anti-factor 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) leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T 4 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 HDL2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels.
  5. Impaired glucose tolerance.
  6. Reduced response to metyrapone test.

Last reviewed on RxList: 5/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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