Vivelle-Dot Side Effects Center

Last updated on RxList: 10/14/2021
Vivelle-Dot Side Effects Center

What Is Vivelle-Dot?

Vivelle-Dot (estradiol transdermal system) is a form of the female hormone estrogen used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Vivelle-Dot reduces urgency or irritation of urination. Vivelle-Dot is also used to treat ovarian disorders, infertility, and abnormal vaginal bleeding. Some estradiol skin patches are used to prevent postmenopausal osteoporosis.

What Are Side Effects of Vivelle-Dot?

Common side effects of Vivelle-Dot include:

  • skin redness/irritation at the application site,
  • nausea,
  • vomiting,
  • upset stomach,
  • constipation,
  • bloating,
  • breast swelling and tenderness,
  • nipple discharge,
  • headache,
  • back pain,
  • joint pain,
  • weight changes,
  • acne,
  • skin color changes,
  • increased facial hair,
  • thinning scalp hair,
  • cold symptoms (stuffy nose, sneezing, sinus pain, sore throat),
  • changes in your menstrual periods, or
  • break-through bleeding.

Tell your doctor if you have serious side effects of Vivelle-Dot including:

  • mental/mood changes (such as depression, memory loss),
  • breast lumps,
  • unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged or recurrent bleeding),
  • increased or new vaginal irritation/itching/odor/discharge,
  • severe stomach or abdominal pain,
  • persistent nausea or vomiting,
  • yellowing eyes or skin,
  • dark urine,
  • swelling hands/ankles/feet, or
  • increased thirst or urination.

Dosage for Vivelle-Dot

Vivelle-Dot transdermal skin patches release the drug slowly, and the dose is absorbed through your skin. The patch is usually replaced twice a week (every 3 to 4 days). Use this medication as directed by your doctor and follow the dosing schedule.

What Drugs, Substances, or Supplements Interact with Vivelle-Dot?

Vivelle-Dot may interact with St. John's wort, phenobarbital, blood thinners, ritonavir, carbamazepine, antibiotics, or antifungals. Tell your doctor all medication you are taking.

Vivelle-Dot During Pregnancy and Breastfeeding

Vivelle-Dot must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding.

Additional Information

Our Vivelle-Dot 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.

QUESTION

If menopause occurs in a woman younger than ___ years, it is considered to be premature. See Answer
Vivelle-Dot Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Remove the skin patch and call your doctor at once if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed;
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
  • swelling or tenderness in your stomach;
  • jaundice (yellowing of the skin or eyes);
  • unusual vaginal bleeding, pelvic pain;
  • a breast lump;
  • memory problems, confusion, unusual behavior; or
  • high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

  • headache, back pain;
  • stuffy nose, sinus pain, sore throat;
  • vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
  • bloating, stomach cramps, nausea, vomiting;
  • breast pain;
  • redness or irritation where the patch was worn;
  • thinning scalp hair; or
  • fluid retention (swelling, rapid weight gain).

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.

SLIDESHOW

What Is Osteoporosis? Treatment, Symptoms, Medication See Slideshow
Vivelle-Dot Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in labeling:

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

There were no clinical trials conducted with Vivelle-Dot. Vivelle-Dot is bioequivalent to Vivelle®. The following adverse reactions have been reported with Vivelle therapy:

Table 1: Summary of Most Frequently Reported Adverse Reactions Regardless of Relationship Reported at a Frequency ≥ 5 Percent

Vivelle 0.025 mg/day†
(N = 47)
N (%)
Vivelle 0.0375 mg/day†
(N = 130)
N (%)
Vivelle 0.05 mg/day†
(N = 103)
N (%)
Vivelle 0.075 mg/day†
(N = 46)
N (%)
Vivelle 0.1 mg/day†
(N = 132)
N (%)
Placebo
(N = 157)
N (%)
Gastrointestinal disorders
Constipation 2 (4.3) 5 (3.8) 4 (3.9) 3 (6.5) 2 (1.5) 4 (2.5)
Dyspepsia 4 (8.5) 12 (9.2) 3 (2.9) 2 (4.3) 0 10 (6.4)
Nausea 2 (4.3) 8 (6.2) 4 (3.9) 0 7 (5.3) 5 (3.2)
General disorders and administration site conditions***
Influenza-like illness 3 (6.4) 6 (4.6) 8 (7.8) 0 3 (2.3) 10 (6.4)
Pain NOS* 0 8 (6.2) 0 2 (4.3) 7 (5.3) 7 (4.5)
Infections and infestations
Influenza 4 (8.5) 4 (3.1) 6 (5.8) 0 10 (7.6) 14 (8.9)
Nasopharyngitis 3 (6.4) 16 (12.3) 10 (9.7) 9 (19.6) 11 (8.3) 24 (15.3)
Sinusitis NOS* 4 (8.5) 17 (13.1) 13 (12.6) 3 (6.5) 7 (5.3) 16 (10.2)
Upper respiratory
tract infection NOS* 3 (6.4) 8 (6.2) 11 (10.7) 4 (8.7) 6 (4.5) 9 (5.7)
Investigations
Weight increased 4 (8.5) 5 (3.8) 2 (1.9) 2 (4.3) 0 3 (1.9)
Musculoskeletal and connective tissue disorders
Arthralgia 0 11 (8.5) 4 (3.9) 2 (4.3) 5 (3.8) 9 (5.7)
Back pain 4 (8.5) 10 (7.7) 9 (8.7) 4 (8.7) 14 (10.6) 10 (6.4)
Neck pain 3 (6.4) 4 (3.1) 4 (3.9) 0 6 (4.5) 2 (1.3)
Pain in limb 0 10 (7.7) 7 (6.8) 2 (4.3) 6 (4.5) 9 (5.7)
Nervous system disorders
Headache NOS* 7 (14.9) 35 (26.9) 32 (31.1) 23 (50.0) 34 (25.8) 37 (23.6)
Sinus headache 0 12 (9.2) 5 (4.9) 5 (10.9) 2 (1.5) 8 (5.1)
Psychiatric disorders
Anxiety NEC** 3 (6.4) 5 (3.8) 0 0 2 (1.5) 4 (2.5)
Depression 5 (10.6) 4 (3.1) 7 (6.8) 0 4 (3.0) 6 (3.8)
Insomnia 3 (6.4) 6 (4.6) 4 (3.9) 2 (4.3) 2 (1.5) 9 (5.7)
Reproductive system and breast disorders
Breast tenderness 8 (17.0) 10 (7.7) 8 (7.8) 3 (6.5) 17 (12.9) 0
Dysmenorrhea 0 0 0 3 (6.5) 0 0
Intermenstrual
bleeding 3 (6.4) 9 (6.9) 6 (5.8) 0 14 (10.6) 7 (4.5)
Respiratory, thoracic and mediastinal disorders
Sinus congestion 0 4 (3.1) 3 (2.9) 3 (6.5) 6 (4.5) 7 (4.5)
Vascular disorders
Hot flushes NOS* 3 (6.4) 0 3 (2.9) 0 0 6 (3.8)
Hypertension NOS* 2 (4.3) 0 3 (2.9) 0 0 2 (1.3)
†Represents milligrams of estradiol delivered daily by each system
*NOS represents not otherwise specified
**NEC represents not elsewhere classified
***Application site erythema and application site irritation were observed in a small number of patients (3.2% or less of patients across treatment groups)

Postmarketing Experience

The following additional adverse reactions have been identified during post-approval use of Vivelle-Dot. 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

Vaginal hemorrhage and abnormal withdrawal bleeding or flow, breakthrough bleeding, spotting, uterine leiomyomata, vaginitis, vaginal discharge, ovarian cancer, endometrial hyperplasia, dysmenorrhea.

Breast

Enlargement, pain, nipple discharge, fibrocystic breast changes, breast cancer.

Cardiovascular

Deep venous thrombosis, pulmonary embolism, thrombophlebitis.

Gastrointestinal

Nausea, vomiting, abdominal cramps, bloating, cholelithiasis, liver function tests abnormal, diarrhea.

Skin

Application site reactions include localized bleeding, bruising, burning, discomfort, dryness, eczema, edema, erythema, erythema multiforme, erythema nodosum, inflammation, irritation, pain, papules and vesicles. Other skin reactions include paresthesia, skin discoloration, skin pigmentation, urticaria, swelling, loss of scalp hair, hirsutism, pruritus, and rash.

Eyes

Intolerance to contact lenses.

Central Nervous System

Migraine, dizziness, chorea, nervousness, affect liability, irritability.

Miscellaneous

Decrease in weight, reduced carbohydrate tolerance, edema, arthralgias, leg cramps, changes in libido, purpura, hypersensitivity, anaphylactic reaction, anaphylactoid reaction, angioedema.

DRUG 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 estrogens and may result in adverse reactions.

Read the entire FDA prescribing information for Vivelle-Dot (Estradiol Transdermal System)

© Vivelle-Dot Patient Information is supplied by Cerner Multum, Inc. and Vivelle-Dot Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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