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Vivelle-Dot Side Effects

Generic name: estradiol

Medically reviewed by Drugs.com. Last updated on Jan 3, 2024.

Note: This document provides detailed information about Vivelle-Dot Side Effects associated with estradiol. Some dosage forms listed on this page may not apply specifically to the brand name Vivelle-Dot.

Applies to estradiol: transdermal gel/jelly, transdermal patch extended release, transdermal spray.

Other dosage forms:

Important warnings This medicine can cause some serious health issues

Transdermal route (gel/jelly)

Endometrial Cancer, Cardiovascular Disorders, Probable Dementia, and Breast Cancer. Estrogen-Alone Therapy. Endometrial Cancer - There is an increased risk of cancer in a woman with a uterus who uses unopposed estrogens.

Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.

Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.Cardiovascular Disorders and Probable Dementia - The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.Cardiovascular Disorders and Probable Dementia - Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia.Cardiovascular Disorders and Probable Dementia - Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI.

Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known.

Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products.

Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.Cardiovascular Disorders and Probable Dementia - Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen Plus Progestin Therapy. Cardiovascular Disorders and Probable Dementia - The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with combined medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo.

It is unknown whether this finding applies to younger postmenopausal women.Cardiovascular Disorders and Probable Dementia - Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia.Breast Cancer - The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Breast Cancer - Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI.

Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known.

Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products.

Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.Breast Cancer - Prescribe estrogens with or without progestogen at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Transdermal route (patch, extended release; gel/jelly)

Estrogen Alone Therapy. Endometrial Cancer - There is an increased risk of cancer in a woman with a uterus who uses unopposed estrogens.

Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.

Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding Cardiovascular Disorders and Probable Dementia - Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.Cardiovascular Disorders and Probable Dementia - The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo.

It is unknown whether this finding applies to younger postmenopausal women.Cardiovascular Disorders and Probable Dementia - In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.Cardiovascular Disorders and Probable Dementia - Only daily oral 0.625 mg CE was studied in the estrogen -alone substudy of the WHI.

Therefore, thee relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known.

Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products.

Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.Cardiovascular Disorders and Probable Dementia - Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen Plus Progestin Therapy. Cardiovascular Disorders and Probable Dementia - Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.Cardiovascular Disorders and Probable Dementia - The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with combined medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo.

It is unknown whether this finding applies to younger postmenopausal women.Breast Cancer - The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Breast Cancer - In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.Breast Cancer - Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI.

Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known.

Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products.

Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.Breast Cancer - Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Transdermal route (spray)

Estrogen Alone Therapy. Endometrial Cancer - There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.

Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.

Perform adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal genital bleeding.Cardiovascular Disorders and Probable Dementia - The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] alone, relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo.

It is unknown whether this finding applies to younger postmenopausal women.Cardiovascular Disorders and Probable Dementia - Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia.Cardiovascular Disorders and Probable Dementia - Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI.

Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known.

Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products.

Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.Cardiovascular Disorders and Probable Dementia - Prescribe estrogens with or without progestogen should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Estrogen Plus Progestin Therapy. Cardiovascular Disorders and Probable Dementia - The WHI estrogen plus progestin substudy reported increased risks of pulmonary embolism (PE), DVT, stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.Cardiovascular Disorders and Probable Dementia - The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo.

It is unknown whether this finding applies to younger postmenopausal women.Cardiovascular Disorders and Probable Dementia - Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia.Breast Cancer - The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.Breast Cancer - Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestogen substudy of the WHI.

Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known.

Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products.

Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.Breast Cancer - Prescribe estrogens with or without progestogen should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.Unintentional Secondary Exposure. Breast budding and breast masses in prepubertal females and gynecomastia and breast masses in prepubertal males have been reported following unintentional secondary exposure to estradiol transdermal spray by women using this product.

In most cases, the condition resolved with the removal of the estradiol transdermal spray exposure.

Women should ensure that children should not come in contact with the site(s) where estradiol transdermal spray is applied.

Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. These visits may be every 3 to 6 months. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise. Be sure to keep all appointments.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine may increase your risk for having blood clots, strokes, or heart attacks. This risk may continue even after you stop using the medicine. Your risk for these serious problems is even greater if you have high blood pressure, high cholesterol in your blood, diabetes, or if you are overweight or smoke cigarettes. Contact your doctor immediately if you experience confusion, difficulty speaking, double vision, headaches, an inability to move arms, legs or facial muscle, or an inability to speak.

Using this medicine over a long period of time may increase your risk of breast cancer, endometrial cancer, or uterine cancer. Do not use this medicine if you have had your uterus (womb) removed (hysterectomy). Check with your doctor immediately if you experience abnormal vaginal bleeding.

Using this medicine may increase your risk of dementia, especially in women 65 years of age and older.

Using this medicine may increase your risk for gallbladder disease. Talk with your doctor about this risk.

Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine. This medicine may also affect the results of certain medical tests.

Check with your doctor immediately if severe headache or sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your child's doctor right away if your child starts to have nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to this medicine.

Do not allow your pets to lick or touch the arm where this medicine was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have nipple or breast enlargement, swelling of the vulva, or any signs of illness.

Do not take other medicines or drink grapefruit juice unless you discuss it with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Common side effects of Vivelle-Dot

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:

Less common side effects

  • back pain
  • difficulty with moving
  • muscle aches, pain, or stiffness
  • stuffy or runny nose

Incidence not known

  • decreased interest in sexual intercourse
  • heavy bleeding
  • increased hair growth, especially on the face
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • irritability
  • leg cramps
  • loss in sexual ability, desire, drive, or performance
  • loss of scalp hair
  • mental depression
  • mood disturbances
  • patchy brown or dark brown discoloration of the skin
  • redness of the skin
  • twitching, uncontrolled movements of the tongue, lips, face, arms, or legs
  • weight changes

Serious side effects of Vivelle-Dot

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:

Incidence not known

  • acid or sour stomach
  • anxiety
  • backache
  • belching
  • blistering, peeling, or loosening of the skin
  • bloating
  • blurred vision
  • breast tenderness, enlargement, pain, or discharge
  • change in vaginal discharge
  • changes in skin color
  • changes in vision
  • chest pain, discomfort, or tightness
  • chills
  • clay-colored stools
  • clear or bloody discharge from the nipple
  • confusion
  • constipation
  • cough
  • darkening of the urine
  • diarrhea
  • difficulty with swallowing
  • dimpling of the breast skin
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • fever
  • fluid-filled skin blisters
  • full or bloated feeling or pressure in the stomach
  • headache
  • headache, severe and throbbing
  • heartburn
  • hives, itching, skin rash
  • indigestion
  • inverted nipple
  • irregular heartbeat
  • itching of the vagina or genital area
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • loss of bladder control
  • lump in the breast or under the arm
  • migraine headache
  • mood or mental changes
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle spasm or jerking of all extremities
  • nausea
  • noisy breathing
  • numbness and tingling around the mouth, fingertips, or feet
  • pain during sexual intercourse
  • pain in the ankles or knees
  • pain or discomfort in the arms, jaw, back, or neck
  • pain or feeling of pressure in the pelvis
  • pain, redness, or swelling in the arm, foot, or leg
  • painful, red lumps under the skin, mostly on the legs
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • persistent crusting or scaling of the nipple
  • poor insight and judgment
  • problems with memory or speech
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • redness or swelling of the breast
  • seizures
  • sensitivity to the sun
  • skin thinness
  • sore on the skin of the breast that does not heal
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach cramps, discomfort, upset, pain, or swelling
  • sudden loss of consciousness
  • sudden trouble breathing
  • sweating
  • thick, white vaginal discharge with no odor or with a mild odor
  • tremor
  • trouble recognizing objects
  • trouble thinking and planning
  • trouble walking
  • unexpected or excess milk flow from the breasts
  • unpleasant breath odor
  • unusual tiredness or weakness
  • unusually heavy or unexpected menstrual bleeding
  • vaginal bleeding or spotting
  • vomiting
  • vomiting of blood
  • yellow eyes or skin
Managing side effects (general information)

For healthcare professionals

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

General adverse events

The most common adverse reactions associated with use of estradiol (the active ingredient contained in Vivelle-Dot) (oral, transdermal spray/gel/film/patches, vaginal ring, IM injection) include breast pain, abdominal pain, back pain, arthralgia, headache, infection, nasopharyngitis, sinusitis, sinus headache, and upper respiratory tract infection.[Ref]

Cardiovascular

Dermatologic

Gastrointestinal

Genitourinary

Hematologic

Hepatic

Hypersensitivity

Local

Metabolic

Musculoskeletal

Nervous system

Ocular

Oncologic

Other

Psychiatric

Renal

Respiratory

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References

1. (2024) "Product Information. Estradiol (estradiol)." Alexso Inc

2. (2024) "Product Information. EstroGel Pump (estradiol)." Ascend Therapeutics

3. (2023) "Product Information. Elestrin Pump (estradiol)." Meda Pharmaceuticals

4. (2024) "Product Information. Progynova (estradiol)." Bayer Plc

5. (2023) "Product Information. Femring (estradiol)." Millicent Pharma

6. (2024) "Product Information. Minivelle (estradiol)." Noven Pharmaceuticals, Inc.

7. (2024) "Product Information. Dotti (estradiol)." Amneal Pharmaceuticals LLC

8. (2024) "Product Information. Lyllana (estradiol)." Amneal Pharmaceuticals

9. (2023) "Product Information. Vivelle-Dot (estradiol)." Sandoz Inc

10. (2023) "Product Information. Climara (estradiol)." Bayer Pharmaceutical Inc

11. (2023) "Product Information. Alora (estradiol)." Allergan Inc

12. (2024) "Product Information. Estradiol Patch (estradiol)." Mylan Pharmaceuticals Inc

13. (2023) "Product Information. Menostar (estradiol)." Berlex Laboratories

14. (2023) "Product Information. Divigel (estradiol)." Vertical Pharmaceuticals Inc

15. (2024) "Product Information. Evamist (estradiol)." Padagis

16. (2024) "Product Information. Depo-Estradiol (estradiol)." Pfizer U.S. Pharmaceuticals Group

17. (2024) "Product Information. Delestrogen (estradiol)." Bristol-Myers Squibb

18. (2023) "Product Information. Estrofem (estradiol)." Novo Nordisk Pharmaceuticals Pty Ltd

19. (2025) "Product Information. Zumenon (estradiol)." Solvay Biosciences Pty Ltd

20. (2021) "Product Information. Progynova (estradiol)." Bayer Australia Limited

21. (2024) "Product Information. Estraderm MX (estradiol)." Juno Pharmaceuticals Pty Ltd

22. (2024) "Product Information. Estradot 50 (estradiol)." Sandoz Pty Ltd

23. (2021) "Product Information. Climara (estradiol)." Bayer Australia Limited

24. (2023) "Product Information. Estrogel (estradiol)." Besins Healthcare Australia Pty Ltd

25. (2025) "Product Information. Sandrena (estradiol)." Organon (Australia) Pty Ltd

26. (2025) "Product Information. Elleste Solo (estradiol)." Exeltis UK Ltd

27. (2023) "Product Information. Zumenon (estradiol)." Waymade Ltd

28. (2023) "Product Information. Estraderm MX (estradiol)." Norgine Pharmaceuticals Ltd

29. (2024) "Product Information. Estradot 50 (estradiol)." Sandoz Ltd

30. (2024) "Product Information. Progynova TS (estradiol)." Bayer Plc

31. (2024) "Product Information. Lenzetto (estradiol)." Gedeon Richter (UK) Ltd

32. (2025) "Product Information. Sandrena (estradiol)." Orion Pharma (UK) Ltd

33. (2023) "Product Information. Oestrogel Pump-Pack (estradiol)." Besins Healthcare (UK) Ltd

34. (2025) "Product Information. Evorel (estradiol)." Theramex HQ UK Ltd

Further information

Vivelle-Dot side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer