Divigel

Divigel (estradiol) is a low-dose gel form of estrogen prescribed to women who suffer from hot flashes and night sweats associated with menopause. Common side effects of Divigel include:

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

Less common, but serious side effects of Divigel include:

• breast cancer
• cancer of the uterus
• stroke
• heart attack
• blood clots
• dementia
• gallbladder disease
• ovarian cancer

Divigel is available as estradiol gel, lotion, or spray (0.25 mg estradiol). Patients should start Divigel at the lowest effective dose for as long as needed. Patients should talk with their healthcare providers at regular intervals about the dose being taken and whether treatment with Divigel is still necessary. Divigel may interact with St. John's wort, blood thinners, ritonavir, carbamazepine, phenobarbital, antibiotics, or antifungal medications. Tell your doctor all medications and supplements you use. Patients who think they may be pregnant should not use or handle Divigel. Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of breast milk. Detectable amounts of estrogens have been identified in the breast milk of mothers receiving estrogen therapy. Caution should be exercised when estrogen products, including Divigel, are administered to a nursing woman.

Our Divigel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Divigel 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 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 Divigel (Estradiol Gel)

 

Divigel Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

• Cardiovascular Disorders [see BOX WARNING,WARNINGS AND PRECAUTIONS].
• Malignant Neoplasms [see BOX WARNING,WARNINGS AND PRECAUTIONS].

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.

Divigel was studied at doses of 0.25, 0.5 and 1.0 gram per day in a 12-week, double-blind, placebo-controlled study that included a total of 495 postmenopausal women (86.5 percent Caucasian). The adverse events that occurred at a rate greater than 5 percent and greater than placebo in any of the treatment groups are summarized in Table 1.

Table 1: Number (%) of Subjects with Common Adverse Reaction*in a 12-Week Placebo-Controlled Study of Divigel

	Divigel			Placebo
SYSTEM ORGAN CLASS    Preferred Term	0.25 g/day	0.5 g/day	1.0 g/day
	N=122	N=123	N=125	N=125
	n (%)	n (%)	n (%)	n (%)
INFECTIONS & INFESTATIONS
Nasophayngitis	7 (5.7)	5 (4.1)	6 (4.8)	5 (4.0)
Upper RespiratoryTract Infection	7 (5.7)	3 (2.4)	2 (1.6)	2 (1.6)
Vaginal mycosis	1 (0.8)	3 (2.4))	8 (6.4)	4 (3.2)
REPRODUCTIVE SYSTEM & BREAST DISORDERS
Breast Tenderness	3 (2.5)	7 (5.7)	11 (8.8)	2 (1.6)
Metrorrhagia	5 (4.1)	7 (5.7)	12 (9.6)	2 (1.6)
*Adverse reactions reported by >5 percent of patient in any treatment group

In a 12-week placebo-controlled study of Divigel, application site reactions were seen in <1 percent of subjects.

Postmarketing Experience

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

Amenorrhea, dysmenorrhea, ovarian cyst, vaginal discharge

Breasts

Gynecomastia

Cardiovascular

Palpitations, ventricular extrasystoles

Gastrointestinal

Flatulence

Skin

Rash pruritic, urticaria

Eyes

Retinal vein occlusion

Central Nervous System

Tremor

Miscellaneous

Arthralgia, application site rash, asthenia, chest discomfort, fatigue, feeling abnormal, heart rate increased, insomnia, malaise, muscle spasms, pain in extremity, weight increased

Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.

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