Omacor and Gallstones - a phase IV clinical study of FDA data

Summary:

Gallstones is reported as a side effect among people who take Omacor (omega-3acid ethyl esters), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Byetta, and have Diabetes.

The phase IV clinical study analyzes which people have Gallstones when taking Omacor. It is created by eHealthMe based on reports of 2,506 people who have side effects when taking Omacor from the FDA, and is updated regularly.

What is Omacor?

Omacor has active ingredients of omega-3acid ethyl esters. It is often used in high blood cholesterol. eHealthMe is studying from 2,547 Omacor users. Check the latest studies of Omacor.

What is Gallstones?

Gallstones (stone formation by bile component) is found to be associated with 1,805 drugs and 2,099 conditions by eHealthMe. Check the latest studies of Gallstones.

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, 09, 2026

2,506 people reported to have side effects when taking Omacor.
Among them, 21 people (0.84%) have Gallstones.

Could Omacor cause Gallstones?

Among these 21 people:

How long have people been on Omacor when they have Gallstones? *

  • < 1 month: 100 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Gallstones when taking Omacor? *

  • female: 42.86 %
  • male: 57.14 %

What is the age of people who have Gallstones when taking Omacor? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 0.0 %
  • 50-59: 6.67 %
  • 60+: 93.33 %

What are other drugs people take besides Omacor? *

  1. Byetta: 13 people, 61.90%
  2. Lisinopril: 9 people, 42.86%
  3. Aspirin: 9 people, 42.86%
  4. Tricor: 8 people, 38.10%
  5. Nexium: 8 people, 38.10%
  6. Actos: 8 people, 38.10%
  7. Vytorin: 8 people, 38.10%
  8. Lantus: 7 people, 33.33%
  9. Diovan: 7 people, 33.33%
  10. Plavix: 7 people, 33.33%

What are other side effects people have besides Gallstones? *

  1. Pancreatitis (inflammation of pancreas): 10 people, 47.62%
  2. Liver Function Test Abnormal: 8 people, 38.10%
  3. Pancreatitis Acute (sudden inflammation of pancreas): 7 people, 33.33%
  4. Abdominal Pain: 6 people, 28.57%
  5. Bowel Movement Irregularity: 6 people, 28.57%
  6. Appetite - Decreased (decreased appetite occurs when you have a reduced desire to eat): 6 people, 28.57%
  7. Chronic Obstructive Pulmonary Disease (a progressive disease that makes it hard to breathe): 6 people, 28.57%
  8. Fatigue (feeling of tiredness): 5 people, 23.81%
  9. Abdominal Pain Upper: 4 people, 19.05%
  10. Gastritis (inflammation of stomach): 4 people, 19.05%

What are the existing conditions these people have? *

  1. Diabetes: 3 people, 14.29%
  2. Thyroid Diseases: 2 people, 9.52%
  3. Heart Disease: 2 people, 9.52%
  4. Glucose Tolerance Impaired (blood glucose is raised beyond normal levels, but not high enough to warrant a diabetes diagnosis): 2 people, 9.52%
  5. Weight Loss: 1 person, 4.76%
  6. Type 2 Diabetes: 1 person, 4.76%
  7. Psoriasis (immune-mediated disease that affects the skin): 1 person, 4.76%
  8. Percutaneous Coronary Intervention: 1 person, 4.76%
  9. Oedema (fluid collection in tissue): 1 person, 4.76%
  10. High Blood Pressure: 1 person, 4.76%

* Approximation only. Some reports may have incomplete information.

Do you take Omacor and have Gallstones?

- Check whether Gallstones 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 Omacor:

Gallstones treatments and more:

How severe was Gallstones and when was it recovered:

Expand to all the drugs that have ingredients of omega-3acid ethyl esters:

Sub-studies by gender and age:

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

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

Browse all side effects of Omacor:

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 Gallstones:

Browse all the conditions that are associated with Gallstones:


How the study uses the data?

The study uses data from the FDA. It is based on omega-3acid ethyl esters (the active ingredients of Omacor) and Omacor (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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