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EstroGel

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EstroGel

EstroGel

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 EstroGel (estradiol gel) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No drug-drug interaction studies have been conducted for EstroGel.

Metabolic Interactions

In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice may increase plasma concentrations of estrogen and may result in side effects.

Last reviewed on RxList: 4/4/2014
This monograph has been modified to include the generic and brand name in many instances.

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EstroGel - User Reviews

EstroGel User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication EstroGel sorted by most helpful. Patient Discussions FAQs

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.


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