Recommended Topic Related To:

Esclim

"March 14, 2013 -- Hormone replacement therapy is the most effective treatment for symptoms like hot flashes, and the benefits are likely to outweigh the risks, major medical societies say.

The statement was published in the April issue "...

Esclim

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

Esclim

Esclim Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Esclim (estradiol) Transdermal System is a form of the female hormone estrogen used to treat moderate to severe vasomotor symptoms associated with menopause, vulval and vaginal atrophy, and hypoestrogenism due to hypogonadism, castration, or primary ovarian failure. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include skin redness/irritation at the application site, nausea/vomiting, bloating, breast tenderness, headache, or weight changes

Treatment is generally initiated with the Esclim 0.025 transdermal system applied to the skin twice weekly, but the initial selection of the dose should be based on the evaluation of the severity of the patient's symptomatology and responsiveness to estrogen treatment. Esclim may interact with aromatase inhibitors, fulvestrant, ospemifene, raloxifene, tamoxifen, or toremifene. Tell your doctor all medications and supplements you use. Esclim should not be used during pregnancy. This drug may decrease the quantity and quality of breast milk produced. Consult your doctor before breastfeeding.

Our Esclim (estradiol) Transdermal System Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Esclim FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Esclim (Estradiol Transdermal) »

A A A

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.


Women's Health

Find out what women really need.

Related Drugs
Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations