Slideshows Images Quizzes

Estrasorb

Last reviewed on RxList: 11/29/2016
Estrasorb Side Effects Center

Last reviewed on RxList 6/6/2016

Estrasorb (estradiol) Topical Emulsion is a form of estrogen, a female sex hormone, used to treat certain symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Common side effects of Estrasorb include:

  • skin redness/irritation at the application site
  • nausea
  • vomiting
  • bloating
  • breast tenderness or swelling
  • headache (including migraine)
  • weight changes
  • loss of appetite
  • acne or skin color changes
  • vaginal pain/dryness/discomfort
  • decreased sex drive
  • difficulty having an orgasm
  • swelling
  • dizziness
  • depression
  • break-through bleeding, or
  • vaginal itching or discharge

For the treatment of moderate to severe vasomotor symptoms associated with menopause, the single approved dose of Estrasorb is 3.48 grams daily. Estrasorb may interact with St. John's wort, blood thinners, ritonavir, carbamazepine, phenobarbital, antibiotics, or antifungals. Tell your doctor all medications and supplements you use. Estrasorb must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding.

Our Estrasorb (estradiol) Topical Emulsion 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.

Estrasorb Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using estradiol topical and call your doctor at once if you have a serious side effect such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;
  • pain, swelling, warmth, or redness in one or both legs;
  • abnormal vaginal bleeding;
  • pain, swelling, or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes); or
  • a lump in your breast.

Topical estradiol is absorbed through the skin and can cause premature puberty in a child who comes into contact with this medicine or with skin where the medicine was applied. Call your doctor if a child who has close contact with you develops swollen nipples or enlarged breasts.

Less serious side effects may include:

  • nausea, vomiting, loss of appetite;
  • swollen breasts;
  • acne or skin color changes;
  • vaginal pain, dryness, or discomfort, decreased sex drive, or difficulty having an orgasm;
  • swelling, weight gain;
  • migraine headaches, dizziness, depression; or
  • break-through bleeding, vaginal itching or discharge.

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.

Read the entire detailed patient monograph for Estrasorb (Estradiol Topical Emulsion)

Estrasorb Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in labeling:

Clinical Trials Experience

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.

Table 1 summarizes the treatment-emergent adverse reactions with ESTRASORB therapy.

Table 1: Number (%) of Patients Reporting ≥ 5% Treatment-Emergent Adverse Reactions

Body system/ Preferred term Statistic Placebo
(n = 134)
ESTRASORB 3.45 grams
(n = 139)
Number of subjects with ≥ 1 TEAE n (%) 82 (61) 95 (68)
Body as a whole n (%) 40 (30) 49 (35)
Headache n (%) 17(13) 12 (9)
Infection n (%) 10 (7) 16 (12)
Respiratory n (%) 15(11) 19 (14)
Sinusitis n (%) 6 (4) 9 (6)
Skin and appendages n (%) 7 (5) 15(11)
Pruritus n (%) 0 5 (4)
Urogenital n (%) 20 (15) 44 (32)
Breast pain n (%) 4 (3) 14 (10)
Endometrial disorder n (%) 11 (8) 21(15)
TEAE = Treatment-emergent adverse event.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ESTRASORB. 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.

Genitourinary system

Unusual bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting; dysmenorrheal; 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 gall bladder 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 disturbance; irritability; exacerbation of epilepsy, dementia.

Miscellaneous

Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgia; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

Read the entire FDA prescribing information for Estrasorb (Estradiol Topical Emulsion)

Related Resources for Estrasorb

Read the Estrasorb User Reviews »

© Estrasorb Patient Information is supplied by Cerner Multum, Inc. and Estrasorb Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors