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Divigel

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The statement was published in the April issue "...

Divigel

Divigel Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Divigel (estradiol) is a low-dose gel form of estrogen prescribed to women who suffer from hot flashes and night sweats associated with menopause. Less common, but serious side effects may include breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease, and 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. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Divigel in Detail - Patient Information: Side Effects

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 Divigel (Estradiol Gel) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Divigel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

See BOXED WARNINGS, WARNINGS and PRECAUTIONS.

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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

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

Table 5: Number (%) of Subjects with Common Adverse Events* in a 12-Week Placebo- Controlled Study of Divigel®

SYSTEM ORGAN CLASS Preferred Term Divigel® Placebo
N=125
n (%)
0.25 g/day
N=122
n (%)
0.5 g/day
N=123
n (%)
1.0 g/day
N=125
n (%)
INFECTIONS & INFESTATIONS
  Nasopharyngitis 7 (5.7) 5 (4.1) 6 (4.8) 5 (4.0)
  Upper Respiratory Tract 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 events reported by ≥5% of patients in any treatment group.

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

The following additional adverse reactions have been reported with estrogen and/or progestin therapy.

  1. Genitourinary system: Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding; spotting; dysmenorrhea; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer; vaginal discharge.
  2. Breasts: Tenderness; enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes; breast cancer; nipple pain.
  3. Cardiovascular: Deep and superficial venous thrombosis, pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
  4. Gastrointestinal: Nausea; vomiting; abdominal cramps; bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas; abdominal pain.
  5. Skin: Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus; rash.
  6. Eyes: Retinal vascular thrombosis, intolerance to contact lenses.
  7. Central Nervous System: Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy; dementia.
  8. Miscellaneous: Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides; muscle cramps.

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

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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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