Vivelle-dot

Note: This document contains side effect information about estradiol. Some of the dosage forms listed on this page may not apply to the brand name Vivelle-Dot.

Common side effects of Vivelle-Dot include: headache. Other side effects include: limb pain. See below for a comprehensive list of adverse effects.

Applies to estradiol: vaginal capsule liquid filled, vaginal cream, vaginal insert extended release, vaginal tablet

Other dosage forms:

• transdermal gel/jelly, transdermal patch extended release, transdermal spray

Along with its needed effects, estradiol (the active ingredient contained in Vivelle-Dot) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking estradiol:

Less common

• Vaginal yeast infection

Incidence not known

• Change in vaginal discharge
• clear or bloody discharge from the nipple
• decrease in the amount of urine
• dimpling of the breast skin
• fast heartbeat
• fever
• hives, itching, or rash
• hoarseness
• inverted nipple
• irritation
• joint pain, stiffness, or swelling
• lump in the breast or under the arm
• noisy, rattling breathing
• pain or feeling of pressure in the pelvis
• pain, redness, or swelling in the arm or leg
• persistent crusting or scaling of the nipple
• redness of the skin
• redness or swelling of the breast
• sore on the skin of the breast that does not heal
• swelling of the eyelids, face, fingers, lips, hands, feet, or lower legs
• tightness in the chest
• troubled breathing at rest
• troubled breathing or swallowing
• vaginal bleeding

Get emergency help immediately if any of the following symptoms of overdose occur while taking estradiol:

Symptoms of overdose

• Dizziness
• drowsiness
• nausea
• stomach pain
• tenderness of the breasts
• unusual tiredness or weakness
• vomiting

Some side effects of estradiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• headache
• itching or pain of the vagina or genital area
• thick, white vaginal discharge with mild or no odor
• weight gain

Less common

• Body aches or pain
• chills
• cough
• diarrhea
• ear congestion
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat

Incidence not known

• Feeling sad or empty
• headache, severe and throbbing
• irritability
• lack of appetite
• tiredness
• trouble concentrating
• trouble sleeping
• welts

Applies to estradiol: compounding powder, intramuscular solution, oral tablet, transdermal emulsion, transdermal film extended release, transdermal gel, transdermal spray, vaginal ring

Very common (10% or more): Breast pain (29%)

Common (1% to 10%): Vulvovaginal pruritus, leukorrhea, vaginal hemorrhage, vaginal discharge, vaginal discomfort, menopause symptoms, breakthrough bleeding or spotting, dysmenorrhea, breast swelling, menorrhagia, metrorrhagia, endometrial hyperplasia

Uncommon (0.1% to 1%): Urinary problems

Rare (less than 0.1%): Galactorrhea

Postmarketing reports: Vaginal irritation, vaginal pain, genital pruritus, changes in bleeding pattern, pelvic pain, breast tenderness, vaginal ulceration, uterine fibroids

Very common (10% or more): Abdominal pain (16%),

Common (1% to 10%): Flatulence, nausea, diarrhea

Uncommon (0.1% to 1%): Vomiting

Postmarketing reports: Abdominal distension

Very common (10% or more): Back pain (11%), arthralgia (11%)

Common (1% to 10%): Leg cramps

Common (1% to 10%): Varicose veins, cardiac symptoms (e.g. palpitations)

Uncommon (0.1% to 1%): Hot flush, hypertension, venous thromboembolic disease

Rare (less than 0.1%): Arterial hypertension

Postmarketing reports: Deep vein thrombosis, changes in blood pressure

Very common (10% or more): Headache (18%)

Uncommon (0.1% to 1%): Vertigo, migraine

Rare (less than 0.1%): Aggravation of epilepsy

Postmarketing reports: Migraine aggravated, paresthesia, dizziness

Uncommon (0.1% to 1%): Benign breast neoplasm, increased volume of uterine leiomyoma

Postmarketing reports: Endometrial cancer, breast cancer

Very common (10% or more): Pain (11%)

Common (1% to 10%): Edema

Uncommon (0.1% to 1%): Weight increased, asthenia

Postmarketing reports: Drug ineffectiveness, blood estrogen increase, fatigue, exacerbation of hereditary angioedema

Common (1% to 10%): Depression

Uncommon (0.1% to 1%): Sleep disorders, nervousness, mood swings

Rare (less than 0.1%): Change in libido

Postmarketing reports: Vaginismus, insomnia, anxiety, irritability

Common (1% to 10%): Pruritus

Uncommon (0.1% to 1%): Rash

Rare (less than 0.1%): Skin discoloration, acne

Postmarketing reports: Urticaria, erythematous or pruritic rash, alopecia, hyperhidrosis, night sweats, contact dermatitis, eczema

Uncommon (0.1% to 1%): Vision abnormal NOS

Postmarketing reports: Visual disturbances, contact lens intolerance

Rare (less than 0.1%): Liver function tests abnormalities

Postmarketing reports: Cholestatic jaundice

Rare (less than 0.1%): Glucose intolerance

Postmarketing reports: Fluid retention

Rare (less than 0.1%): Anaphylactic reaction (with a past history of allergic reaction)

Postmarketing reports: Anaphylactic reactions, hypersensitivity

Very common (10% or more): Upper respiratory tract infection (17%)

Common (1% to 10%): Vulvovaginal mycotic infection, pharyngitis, rhinitis, sinusitis, moniliasis genital

Uncommon (0.1% to 1%): Vaginitis/vaginal candidosis

Common (1% to 10%): Skin irritation (topical gel)

Postmarketing reports: Application site reaction