Vivelle and Breast hyperplasia - a phase IV clinical study of FDA data

Summary:

Breast hyperplasia is reported as a side effect among people who take Vivelle (estradiol), especially for people who are 60+ old, have been taking the drug for 1 - 2 years also take Provera, and have Menopause.

The phase IV clinical study analyzes which people have Breast hyperplasia when taking Vivelle. It is created by eHealthMe based on reports of 6,258 people who have side effects when taking Vivelle from the FDA, and is updated regularly.

What is Vivelle?

Vivelle has active ingredients of estradiol. It is often used in hormone replacement therapy. eHealthMe is studying from 6,624 Vivelle users. Check the latest studies of Vivelle.

What is Breast hyperplasia?

Breast hyperplasia (accumulation of abnormal cells in a breast duct) is found to be associated with 123 drugs and 196 conditions by eHealthMe. Check the latest studies of Breast hyperplasia.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.



On Aug, 27, 2026

6,258 people reported to have side effects when taking Vivelle.
Among them, 11 people (0.18%) have Breast hyperplasia.

Could Vivelle cause Breast hyperplasia?

Among these 11 people:

How long have people been on Vivelle when they have Breast hyperplasia? *

  • < 1 month: 0.0 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 60 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 40 %

What is the age of people who have Breast hyperplasia when taking Vivelle? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 11.11 %
  • 50-59: 33.33 %
  • 60+: 55.56 %

What are other drugs people take besides Vivelle? *

  1. Provera: 10 people, 90.91%
  2. Premarin: 9 people, 81.82%
  3. Estraderm: 6 people, 54.55%
  4. Hydrochlorothiazide: 5 people, 45.45%
  5. Accupril: 4 people, 36.36%
  6. Ambien: 4 people, 36.36%
  7. Prempro: 4 people, 36.36%
  8. Estrace: 4 people, 36.36%
  9. Prozac: 4 people, 36.36%
  10. Cycrin: 3 people, 27.27%

What are other side effects people have besides Breast hyperplasia? *

  1. Meniscus Lesion (lesion of a crescent-shaped piece of cartilage between the femur and the tibia): 7 people, 63.64%
  2. Breast Lump (localized swelling that feels different from the surrounding breast tissue): 7 people, 63.64%
  3. Depression: 7 people, 63.64%
  4. Bladder Disorder: 6 people, 54.55%
  5. Urinary Incontinence (inability to control the flow of urine and involuntary urination): 6 people, 54.55%
  6. Breast Cancer In Situ: 6 people, 54.55%
  7. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 6 people, 54.55%
  8. Wound: 5 people, 45.45%
  9. Chest Pain: 5 people, 45.45%
  10. Neurogenic Bladder (the normal function of the bladder is to store and empty urine in a coordinated, controlled fashion): 5 people, 45.45%

What are the existing conditions these people have? *

  1. Menopause (end of monthly cycles in women): 6 people, 54.55%
  2. High Blood Pressure: 5 people, 45.45%
  3. Hot Flush (sudden feelings of heat): 2 people, 18.18%

* Approximation only. Some reports may have incomplete information.

Do you take Vivelle and have Breast hyperplasia?

- Check whether Breast hyperplasia is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
- Get an AI agent to monitor your drugs continuously



Related studies:

Effectiveness of, long term effects of, and alternative drugs to Vivelle:

Breast hyperplasia treatments and more:

How severe was Breast hyperplasia and when was it recovered:

Expand to all the drugs that have ingredients of estradiol:

Sub-studies by age:

0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Vivelle:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Browse all the drugs that are associated with Breast hyperplasia:

Browse all the conditions that are associated with Breast hyperplasia:


How the study uses the data?

The study uses data from the FDA. It is based on estradiol (the active ingredients of Vivelle) and Vivelle (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

How to use the study?

DO NOT STOP MEDICATIONS without first consulting your doctor. If there are any serious or long term adverse effects discovered in the study, discuss the study with your doctor to ensure that proper medication management will be in place if applicable.

Who is eHealthMe?

With medical big data and proven AI/ML algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 800+ peer-reviewed medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).

WARNING, DISCLAIMER, USE FOR PUBLICATION

WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.



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