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Vivelle-Dot Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Vivelle-Dot (estradiol transdermal system) is 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. It is also used to treat ovarian disorders, infertility, and abnormal vaginal bleeding. Some estradiol skin patches are used to prevent postmenopausal osteoporosis. Estradiol is a form of estrogen. Common side effects include skin redness/irritation at the application site, nausea/vomiting, bloating, breast tenderness, headache, or weight changes.
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. 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 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 breast-feeding.
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.
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.
Vivelle-Dot 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.
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, especially on one side of the body;
- sudden severe headache, sudden vision changes, problems with speech or balance;
- sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- pain, swelling, or tenderness in your stomach;
- jaundice (yellowing of the skin or eyes);
- unusual vaginal bleeding;
- a lump in your breast;
- numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
- upset stomach, bloating, constipation;
- acne or skin color changes, increased facial hair, thinning scalp hair;
- mild headache, back pain, joint pain;
- cold symptoms such as stuffy nose, sneezing, sinus pain, sore throat;
- breast swelling and tenderness, nipple discharge; or
- changes in your menstrual periods, break-through bleeding.
Read the entire detailed patient monograph for Vivelle-Dot (Estradiol Transdermal System)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Vivelle-Dot Overview - Patient Information: Side Effects
Skin redness/irritation at the application site, nausea/vomiting, bloating, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), increased or new vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.
This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.
A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Vivelle-Dot (Estradiol Transdermal System)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Vivelle-Dot FDA Prescribing Information: Side Effects
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.
The following adverse events have been reported with Vivelle-Dot® (estradiol transdermal system) (estradiol transdermal system) therapy:
Table 3: Summary of Most Frequently Reported Adverse Experiences/Medical
Events Regardless of Relationship Reported at a Frequency ≥5%
|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)|
|Weight increased||4 (8.5)||5 (3.8)||2 (1.9)||2 (4.3)||0||3 (1.9)|
|Musculoskeletal andconnective 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)|
|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|
|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)|
|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.)
The following additional adverse reactions have been reported with estrogen and/or progestin therapy:
- 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.
- Breasts. Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
- Cardiovascular. Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
- Gastrointestinal.Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.
- Skin. Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
- Eyes. Retinal vascular thrombosis; steepening of corneal curvature; intolerance to contact lenses.
- Central nervous system. Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
- Miscellaneous. Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; anaphylactoid/anaphylactic reactions including urticaria and angioedema; hypocalcemia; exacerbation of asthma; increased triglycerides.
Read the entire FDA prescribing information for Vivelle-Dot (Estradiol Transdermal System)
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