Short answer: The Vivelle-Dot label lists headache, breast tenderness, nasopharyngitis, sinusitis, sinus headache, upper respiratory infection, back pain, depression and irregular bleeding as most common (10% or more). On the 0.05 mg patch, headache was 31.1% vs 23.6% on placebo. Patch site redness and irritation were 3.2% or less. The boxed warning covers endometrial cancer, stroke and clots, dementia and breast cancer.
What Vivelle-Dot is approved for: Vivelle-Dot is an estrogen patch approved to treat moderate to severe hot flashes and moderate to severe vulvar and vaginal atrophy due to menopause, to treat low estrogen from hypogonadism, castration or primary ovarian failure, and to prevent postmenopausal osteoporosis (sections 1.1 to 1.4). For vaginal symptoms alone, topical vaginal products are considered first; for osteoporosis prevention alone, non-estrogen medicines are considered first.
Source
VIVELLE-DOT (estradiol transdermal system), prescribing information and Patient Information. Sandoz. DailyMed, version published July 4, 2024. DailyMed setid 5ccb77f9-d47b-4381-ad5c-5b92524e1c4a
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER
Estrogen-alone therapy: a woman with a uterus who uses estrogen without a progestogen has a higher risk of endometrial cancer; adding a progestogen lowers the risk of endometrial hyperplasia, a possible precursor. Undiagnosed, persistent or recurring abnormal genital bleeding after menopause is checked, including with endometrial sampling when indicated. In the Women's Health Initiative (WHI), daily oral conjugated estrogens (CE) 0.625 mg alone raised the risk of stroke and deep vein thrombosis in women 50 to 79 over 7.1 years, and the WHI Memory Study found a higher risk of probable dementia in women 65 and older over 5.2 years. Estrogen plus progestin therapy: daily CE 0.625 mg plus medroxyprogesterone acetate (MPA) 2.5 mg raised the risk of DVT, pulmonary embolism, stroke, heart attack and invasive breast cancer, and of probable dementia in women 65 and older. Neither is to be used to prevent heart disease or dementia. Only those oral doses were studied, so whether the findings apply to other doses, routes such as a patch, or products is not known. Estrogens, with or without progestogens, are prescribed at the lowest effective dose for the shortest duration consistent with treatment goals and risks.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Vivelle-Dot.
| Adverse reaction | Vivelle 0.025 mg/day (N=47) | Vivelle 0.0375 mg/day (N=130) | Vivelle 0.05 mg/day (N=103) | Vivelle 0.075 mg/day (N=46) | Vivelle 0.1 mg/day (N=132) | Placebo (N=157) |
|---|---|---|---|---|---|---|
| Headache | 7 (14.9) | 35 (26.9) | 32 (31.1) | 23 (50.0) | 34 (25.8) | 37 (23.6) |
| Breast tenderness | 8 (17.0) | 10 (7.7) | 8 (7.8) | 3 (6.5) | 17 (12.9) | 0 |
| Nasopharyngitis | 3 (6.4) | 16 (12.3) | 10 (9.7) | 9 (19.6) | 11 (8.3) | 24 (15.3) |
| Sinusitis | 4 (8.5) | 17 (13.1) | 13 (12.6) | 3 (6.5) | 7 (5.3) | 16 (10.2) |
| Upper respiratory tract infection | 3 (6.4) | 8 (6.2) | 11 (10.7) | 4 (8.7) | 6 (4.5) | 9 (5.7) |
| Back pain | 4 (8.5) | 10 (7.7) | 9 (8.7) | 4 (8.7) | 14 (10.6) | 10 (6.4) |
| Intermenstrual bleeding | 3 (6.4) | 9 (6.9) | 6 (5.8) | 0 | 14 (10.6) | 7 (4.5) |
| Sinus headache | 0 | 12 (9.2) | 5 (4.9) | 5 (10.9) | 2 (1.5) | 8 (5.1) |
| Depression | 5 (10.6) | 4 (3.1) | 7 (6.8) | 0 | 4 (3.0) | 6 (3.8) |
| 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) |
| Arthralgia | 0 | 11 (8.5) | 4 (3.9) | 2 (4.3) | 5 (3.8) | 9 (5.7) |
| Weight increased | 4 (8.5) | 5 (3.8) | 2 (1.9) | 2 (4.3) | 0 | 3 (1.9) |
| Insomnia | 3 (6.4) | 6 (4.6) | 4 (3.9) | 2 (4.3) | 2 (1.5) | 9 (5.7) |
Reported with Vivelle, to which Vivelle-Dot is bioequivalent; there were no clinical trials with Vivelle-Dot itself. Values are number of women (percent) by patch strength in mg of estradiol delivered per day. Application site redness and irritation were seen in 3.2% or less across treatment groups.
WHI, estrogen alone (oral CE 0.625 mg): stroke 45 vs 33 per 10,000 women-years on placebo; blood clots (VTE) 30 vs 22, with DVT 23 vs 15. With a progestin (CE plus MPA): stroke 33 vs 25; VTE 35 vs 17; DVT 26 vs 13; pulmonary embolism 18 vs 8.
Endometrial cancer risk with estrogen alone in a woman with a uterus is about 2 to 12 times that of non-users, and 15 to 24 times with 5 to 10 years or more of use, persisting at least 8 to 15 years after stopping.
WHI estrogen plus progestin: invasive breast cancer 41 vs 33 per 10,000 women-years (relative risk 1.24). Estrogen alone was not linked to more invasive breast cancer (relative risk 0.80). A meta-analysis linked current hormone therapy to ovarian cancer (relative risk 1.41).
WHIMS, women 65 to 79: probable dementia 37 vs 25 per 10,000 women-years with estrogen alone, and 45 vs 22 with estrogen plus progestin.
Reported after approval: breakthrough bleeding and spotting, breast enlargement and pain, DVT and pulmonary embolism, nausea, bloating, gallstones, many application site reactions (bleeding, bruising, burning, itching, redness, blisters), hair loss, contact lens intolerance, migraine, dizziness, changes in libido and anaphylactic reactions, among others.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Who should not use it. Women with undiagnosed abnormal genital bleeding, current or past breast cancer, estrogen-dependent cancer, current or past blood clots, stroke or heart attack, liver impairment or disease, protein C, protein S or antithrombin deficiency or other clotting disorders, or a known anaphylactic reaction, angioedema or allergic reaction to Vivelle-Dot.
Stroke, blood clots and heart attack. Estrogen is stopped right away if a stroke, blood clot or heart attack occurs or is suspected. If feasible, it is stopped at least 4 to 6 weeks before surgery linked to clots or during long immobilization.
Endometrial, breast and ovarian cancer. Estrogen alone raises endometrial cancer risk in women with a uterus. Estrogen plus progestin raised breast cancer risk in WHI, and observational studies show a smaller rise with estrogen alone. Yearly breast exams by a provider and monthly self-exams are advised.
Probable dementia. WHIMS found a higher risk of probable dementia in women 65 to 79 on oral estrogen with or without a progestin. Whether this applies to younger women is unknown.
Gallbladder disease. A 2- to 4-fold rise in gallbladder disease needing surgery has been reported in postmenopausal women taking estrogens.
Vision problems. Blood clots in the retina have been reported. Vivelle-Dot is stopped pending exam for sudden vision loss, bulging eyes, double vision or migraine, and permanently if papilledema or retinal vessel lesions are found.
Triglycerides, liver and calcium. In women with high triglycerides, estrogen can raise them and cause pancreatitis (5.9). It is stopped if jaundice from bile blockage returns (5.10). Estrogen can cause severe high calcium in breast cancer spread to bone (5.5) and low calcium in hypoparathyroidism (5.13).
Allergic reactions and angioedema. A few anaphylactic reactions and cases of angioedema of the eyes, face, throat, tongue or limbs have been reported. Swelling of the tongue or throat may block the airway. Vivelle-Dot is not given again to a woman who develops angioedema on it.
Thyroid, fluid and other conditions. Women on thyroid hormone may need higher doses. Estrogen can cause fluid retention and may worsen endometriosis, asthma, diabetes, epilepsy, migraine, porphyria, lupus and liver hemangiomas (sections 5.11 to 5.16).
From the Patient Information that comes with Vivelle-Dot:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.