Pradaxa and Heart valve surgery - a phase IV clinical study of FDA data

Summary:

Heart valve surgery is reported as a side effect among people who take Pradaxa (dabigatran etexilate mesylate), especially for people who are male, 60+ old, have been taking the drug for 2 - 5 years also take Fabrazyme, and have Stroke.

The phase IV clinical study analyzes which people have Heart valve surgery when taking Pradaxa. It is created by eHealthMe based on reports of 86,033 people who have side effects when taking Pradaxa from the FDA, and is updated regularly.

What is Pradaxa?

Pradaxa has active ingredients of dabigatran etexilate mesylate. It is often used in atrial fibrillation/flutter. eHealthMe is studying from 86,906 Pradaxa users. Check the latest studies of Pradaxa.

What is Heart valve surgery?

Heart valve surgery is found to be associated with 151 drugs and 437 conditions by eHealthMe. Check the latest studies of Heart valve surgery.

On Jul, 14, 2026

86,033 people reported to have side effects when taking Pradaxa.
Among them, 23 people (0.03%) have Heart valve surgery.

Could Pradaxa cause Heart valve surgery?

Among these 23 people:

How long have people been on Pradaxa when they have Heart valve surgery? *

What is the gender of people who have Heart valve surgery when taking Pradaxa? *

female: 43.48 %
male: 56.52 %

What is the age of people who have Heart valve surgery when taking Pradaxa? *

What are other drugs people take besides Pradaxa? *

Fabrazyme: 2 people, 8.70%
Pantoprazole: 1 person, 4.35%
Alendronic Acid: 1 person, 4.35%

What are other side effects people have besides Heart valve surgery? *

Dyspnea (difficult or laboured breathing): 3 people, 13.04%
Cardiac Failure Congestive: 2 people, 8.70%
Ventricular Extrasystoles (premature cardiac contraction): 1 person, 4.35%
Haematemesis (vomiting of blood): 1 person, 4.35%
Anuria (failure of the kidneys to produce urine): 1 person, 4.35%
Blood Creatinine Increased: 1 person, 4.35%
Brachial Plexopathy (pain, decreased movement, or decreased sensation in the arm and shoulder due to a nerve problem): 1 person, 4.35%
Breathing - Slowed Or Stopped: 1 person, 4.35%
Cardiac Arrest: 1 person, 4.35%
Cardiac Disorder: 1 person, 4.35%

What are the existing conditions these people have? *

Stroke (sudden death of a portion of the brain cells due to a lack of oxygen): 3 people, 13.04%
Fabry's Disease (build up of a particular type of fat, called globotriaosylceramide, in the body's cells): 2 people, 8.70%
Heart Rate Irregular: 1 person, 4.35%

* Approximation only. Some reports may have incomplete information.

Do you take Pradaxa and have Heart valve surgery?

- Check whether Heart valve surgery 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 Pradaxa:

Pradaxa (86,906 reports)

Browse all side effects of Pradaxa:

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 Heart valve surgery:

Heart valve surgery (151 drugs)

Browse all the conditions that are associated with Heart valve surgery:

Heart valve surgery (437 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on dabigatran etexilate mesylate (the active ingredients of Pradaxa) and Pradaxa (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.