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Esclim

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Esclim

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Side Effects
Interactions

SIDE EFFECTS

See WARNINGS and Boxed Warning regarding the potential adverse effects on the fetus, the induction of malignant neoplasms, gallbladder disease, cardiovascular disease, elevated blood pressure, and hypercalcemia.

Skin irritation: In controlled clinical studies with Esclim (estradiol transdermal) , the most commonly reported adverse events were topical reactions of erythema and/or pruritus at the application site. In general these reactions caused patients little or no discomfort, and led to premature discontinuation of treatment in 0.9% (3/317) of patients in these trials. The rate of application site reactions, based on 8,135 applications of the 0.025, 0.05, and 0.1 Esclim (estradiol transdermal) systems in these trials was 6.1 per 100 applications (4.9, 5.4, 10.7 for the 3 Esclim (estradiol transdermal) doses respectively) compared to 6.2 in the placebo treated patients (2,014 applications).

In a placebo-controlled trial of Esclim (estradiol transdermal) 0.025, 0.05, and 0.1 conducted in 196 patients in the US, the adverse events reported by at least 5% of patients in 1 or more of the treatment groups are shown in Table 5.

Table 5: Incidence of Adverse Events >5% in a Placebo-Controlled Study of Esclim Data Are Expressed as % of Treatment Group

 

Placebo

Esclim

Esclim

Esclim

Adverse Event

 

0.025 mg/day

0.05 mg/day

0.1 mg/day

 

(N=54)

(N=48)

(N=47)

(N=47)

Breast Pain

3.7

25.0

44.7

46.8

Headache

22.2

18.8

8.5

6.4

Infection

7.4

10.4

10.6

8.5

Injury Accident

3.7

10.4

4.3

2.1

Anxiety

0

8.3

2.1

0

Emotional Lability

1.9

8.3

2.1

6.4

Arthralgia

1.9

6.3

2.1

4.3

Flu Syndrome

7.4

6.3

6.4

8.5

Joint Disorder

0

6.3

0

0

Pruritus

1.9

6.3

12.8

0

Rhinitis

1.9

6.3

4.3

4.3

Abdominal Pain

9.3

4.2

10.6

2.1

General Edema

1.9

4.2

6.4

6.4

Monilia Vagina

5.6

4.2

8.5

4.3

Nausea

1.9

4.2

10.6

8.5

Peripheral Edema

0

4.2

2.1

6.4

Sinusitis

7.4

4.2

2.1

4.3

Asthenia

1.9

2.1

10.6

6.4

Back Pain

3.7

2.1

2.1

6.4

Diarrhea

1.9

2.1

8.5

0

Dysmenorrhea

0

2.1

2.1

6.4

Enlarged Abdomen

0

2.1

2.1

6.4

Enlarged Breast

0

2.1

2.1

8.5

Rash

5.6

2.1

4.3

2.1

Anemia

0

0

6.4

4.3

Gastroenteritis

1.9

0

0

6.4

Hyperlipemia

5.6

0

0

2.1

Leukorrhea

0

0

12.8

0

Paresthesia

1.9

0

6.4

0

Urogenital Adverse Events (See Precautions: Addition of a progestin): In the US placebo-controlled study, 72 patients were included who had intact uteri. As expected, after 12-13 weeks of continuous unopposed therapy, findings of endometrial hyperplasia (diagnosed either by endometrial biopsy and/or ultrasonography) were increased with increasing doses of estradiol (placebo: 0/18 patients; Esclim (estradiol transdermal) 0.025: 1/14 (7.1%); Esclim (estradiol transdermal) 0.05: 12/22 (54.5%); Esclim (estradiol transdermal) 0.1: 10/18 (55.6%). In the 86 patients who had not previously undergone a total hysterectomy, vaginal bleeding was also increased with increasing doses of estradiol [placebo: 2/21 patients (9.5%); Esclim (estradiol transdermal) 0.025: 6/19 (31.6%); Esclim (estradiol transdermal) 0.05: 14/25 (56.0%); Esclim (estradiol transdermal) 0.1: 12/21 (57.1%)].

In 2 long-term studies involving a total of 488 patients treated for a mean duration of 618 days and up to 3.5 years, the nature and incidence of adverse events did not change with prolonged duration of treatment.

The following additional adverse reactions have been reported with estrogen therapy:

1. Genitourinary System. Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting; increase in size of uterine leiomyomata; vaginal candidiasis; change in amount of cervical secretion.

2. Breasts. Tenderness, enlargement.

3. Gastrointestinal. Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; gallbladder disease.

4. Skin. Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism.

5. Eyes. Steepening of corneal curvature: intolerance to contact lenses.

6. Central Nervous System. Headache, migraine, dizziness; mental depression; chorea.

7. Miscellaneous. Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; changes in libido.

Read the Esclim (estradiol transdermal) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drug/Laboratory Tests Interactions

Some of these drug/laboratory test interactions have been observed only with estrogen-progestin combinations (oral contraceptives):

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, 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.

3. Other binding proteins may be elevated in serum, i.e. corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG), leading to increased circulating corticosteroids and sex steroids respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).

4. Increased plasma HDL and HDL-2 subfraction concentrations, reduced LDL cholesterol concentration, increased triglyceride levels.

5. Impaired glucose tolerance.

6. Reduced response to metyrapone test.

7. Reduced serum folate concentration.

 

Last reviewed on RxList: 1/12/2005
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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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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