Slideshows Images Quizzes

EstroGel

Last reviewed on RxList: 4/4/2014
EstroGel Side Effects Center

Last reviewed on RxList 8/5/2016

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:

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

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.

EstroGel 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 EstroGel (Estradiol Gel)

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.

Health Solutions From Our Sponsors