Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

EstroGel

Last reviewed on RxList: 7/20/2018
EstroGel Side Effects Center

Last reviewed on RxList 7/20/2018

EstroGel 0.06% (estradiol) Gel is a form of the female hormone estrogen indicated for moderate to severe hot flashes due to menopause, and moderate to severe menopausal changes in or around the vagina. Common side effects of EstroGel include:

The recommended dosage of EstroGel is 1.25 g. St. John's wort, blood thinners, ritonavir, carbamazepine, erythromycin, Ketozole, and itraconazole may interact with EstroGel. Tell your doctor all medications you take. Children should avoid coming into contact with EstroGel. Do not use EstroGel if you are pregnant or breastfeeding.

Our EstroGel (estradiol) Gel 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.

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
EstroGel Consumer Information

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

Call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • swelling or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • memory problems, confusion, unusual behavior;
  • unusual vaginal bleeding, pelvic pain;
  • a lump in your breast; or
  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Topical estradiol is absorbed through the skin of a child who comes into contact with this medicine. Call your doctor if a child in close contact with you develops swollen nipples or enlarged breasts.

Common side effects may include:

  • nausea, vomiting, stomach cramps;
  • bloating, swelling, weight gain;
  • breast pain or tenderness;
  • headache;
  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
  • thinning scalp hair; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 EstroGel (Estradiol Gel)

SLIDESHOW

What Is Osteoporosis? Treatment, Symptoms, Medication See Slideshow
EstroGel Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the 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 clinical practice.

EstroGel was studied in 2 well-controlled, 12-week clinical trials. Incidence of adverse drug reactions ≥ 5 percent for 1.25 g EstroGel 0.06% and placebo is given in Table 1.

TABLE 1 : Incidence of Adverse Drug Reactions ≥ 5 Percent Occurrence in the EstroGel Treatment Group for the Intent-to-Treat Safety Population in 2 Well-controlled Clinical Studies (Expressed as Percent of Treatment Group)

Body System/ Adverse Drug Reactions EstroGel 0.06% 1.25 g /day
(n=168)
Placebo
(n=73)
BODY AS A WHOLE
  Headache 9.5 2.7
DIGESTIVE SYSTEM
  Flatulence 5.4 4.1
UROGENITAL SYSTEM
  Breast pain 10.7 8.2

In 2 controlled clinical trials, application site reactions were reported by 0.6 percent of patients who received 1.25 g of EstroGel. Other skin reactions, such as pruritus and rash, were also noted.

Postmarketing Experience

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

Endometrial cancer

Breast

Pain; tenderness; breast cancer

Cardiovascular

Deep vein thrombosis; myocardial ischemia; phlebitis

Gastrointestinal

Nausea; abdominal distension; diarrhea; stomach discomfort

Skin

Alopecia; rash; pruritus; application site: dryness, pain, discoloration, reaction, rash

Eyes

Retinal vein occlusion

Central Nervous System

Headache; dizziness; insomnia; hypoesthesia; meningioma; aphasia; bradyphrenia; paresthesia

Miscellaneous

Drug ineffective; hot flush; arthralgia; night sweats; drug effect decreased; pain in extremity; fatigue; weight increased; pain; hypersensitivity; dyspnea; malignant mesenchymoma; angioedema; hepatitis acute; face edema; accidental exposure; myoclonus; gait disturbance; flushing

Read the entire FDA prescribing information for EstroGel (Estradiol Gel)

Related Resources for EstroGel

Related Health

Read the EstroGel User Reviews »

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

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED SLIDESHOW