EstroGel

Last updated on RxList: 4/12/2021
EstroGel Side Effects Center

What Is EstroGel?

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.

What Are Side Effects of EstroGel?

Common side effects of EstroGel include:

Dosage for EstroGel

The recommended dosage of EstroGel is 1.25 g.

What Drugs, Substances, or Supplements Interact with EstroGel?

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.

EstroGel During Pregnancy and Breastfeeding

Do not use EstroGel if you are pregnant or breastfeeding.

Additional Information

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.

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EstroGel Consumer Information

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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 blood clot--sudden numbness or weakness, sudden vision loss, slurred speech, stabbing chest pain, coughing up blood, pain or warmth in one or both legs;
  • swelling or tenderness in your stomach, severe stomach pain spreading to your back, nausea and vomiting;
  • jaundice (yellowing of the skin or eyes);
  • memory problems, confusion, unusual behavior;
  • unusual vaginal bleeding, pelvic pain;
  • a lump in your breast; or
  • high calcium levels--confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss.

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)

QUESTION

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

© 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.

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