Soliris and Uterine leiomyoma - a phase IV clinical study of FDA data

Summary:

Uterine leiomyoma is reported as a side effect among people who take Soliris (eculizumab), especially for people who are 40-49 old, have been taking the drug for < 1 month also take Folic Acid, and have Paroxysmal nocturnal haemoglobinuria.

The phase IV clinical study analyzes which people have Uterine leiomyoma when taking Soliris. It is created by eHealthMe based on reports of 58,774 people who have side effects when taking Soliris from the FDA, and is updated regularly.

What is Soliris?

Soliris has active ingredients of eculizumab. It is often used in paroxysmal nocturnal hemoglobinuria (pnh). eHealthMe is studying from 58,821 Soliris users. Check the latest studies of Soliris.

What is Uterine leiomyoma?

Uterine leiomyoma (uterine benign tumour derived from smooth muscle) is found to be associated with 786 drugs and 709 conditions by eHealthMe. Check the latest studies of Uterine leiomyoma.



On Jul, 15, 2026

58,774 people reported to have side effects when taking Soliris.
Among them, 44 people (0.07%) have Uterine leiomyoma.

Could Soliris cause Uterine leiomyoma?

Among these 44 people:

How long have people been on Soliris when they have Uterine leiomyoma? *

  • < 1 month: 66.67 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 11.11 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 22.22 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the age of people who have Uterine leiomyoma when taking Soliris? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 7.14 %
  • 30-39: 14.29 %
  • 40-49: 64.29 %
  • 50-59: 7.14 %
  • 60+: 7.14 %

What are other drugs people take besides Soliris? *

  1. Folic Acid: 5 people, 11.36%
  2. Coumadin: 3 people, 6.82%
  3. Benadryl: 3 people, 6.82%
  4. Lisinopril: 2 people, 4.55%
  5. Metoprolol Tartrate: 2 people, 4.55%
  6. Danazol: 1 person, 2.27%
  7. Fluvastatin: 1 person, 2.27%
  8. Flexeril: 1 person, 2.27%
  9. Fiorinal: 1 person, 2.27%
  10. Exjade: 1 person, 2.27%

What are other side effects people have besides Uterine leiomyoma? *

  1. Fatigue (feeling of tiredness): 13 people, 29.55%
  2. Abdominal Pain: 10 people, 22.73%
  3. Dyspnea (difficult or laboured breathing): 9 people, 20.45%
  4. Anaemia (lack of blood): 7 people, 15.91%
  5. Haemoglobin Decreased: 7 people, 15.91%
  6. Heavy Or Prolong Menstrual Bleeding: 7 people, 15.91%
  7. Nausea (feeling of having an urge to vomit): 7 people, 15.91%
  8. Nausea And Vomiting: 6 people, 13.64%
  9. Deep Venous Thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis): 6 people, 13.64%
  10. Fever: 6 people, 13.64%

What are the existing conditions these people have? *

  1. Paroxysmal Nocturnal Haemoglobinuria (haemoglobin in the urine): 29 people, 65.91%
  2. Haemolytic Uraemic Syndrome (blood clotting disease caused by e. coli infection, birth control pills, pneumonia, medications, and more): 10 people, 22.73%
  3. High Blood Pressure: 2 people, 4.55%
  4. Vulvovaginal Dryness: 1 person, 2.27%
  5. Quit Smoking: 1 person, 2.27%
  6. Myasthenia Gravis (a chronic condition that causes muscles to tire and weaken easily): 1 person, 2.27%
  7. High Blood Cholesterol: 1 person, 2.27%
  8. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 1 person, 2.27%
  9. Diabetes: 1 person, 2.27%
  10. Depression: 1 person, 2.27%

* Approximation only. Some reports may have incomplete information.

Do you take Soliris and have Uterine leiomyoma?

- Check whether Uterine leiomyoma 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 Soliris:

Uterine leiomyoma treatments and more:

How severe was Uterine leiomyoma and when was it recovered:

Expand to all the drugs that have ingredients of eculizumab:

Sub-studies by age:

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

Browse all side effects of Soliris:

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 Uterine leiomyoma:

Browse all the conditions that are associated with Uterine leiomyoma:


How the study uses the data?

The study uses data from the FDA. It is based on eculizumab (the active ingredients of Soliris) and Soliris (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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