Pradaxa and Calculus bladder - a phase IV clinical study of FDA data

Summary:

Calculus bladder 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 < 1 month also take Metformin, and have Stroke.

The phase IV clinical study analyzes which people have Calculus bladder 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 Calculus bladder?

Calculus bladder (bladder stone) is found to be associated with 209 drugs and 621 conditions by eHealthMe. Check the latest studies of Calculus bladder.

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 Sep, 01, 2026

86,033 people reported to have side effects when taking Pradaxa.
Among them, 26 people (0.03%) have Calculus bladder.

Among these 26 people:

How long have people been on Pradaxa when they have Calculus bladder? *

What is the gender of people who have Calculus bladder when taking Pradaxa? *

female: 7.69 %
male: 92.31 %

What is the age of people who have Calculus bladder when taking Pradaxa? *

What are other drugs people take besides Pradaxa? *

What are other side effects people have besides Calculus bladder? *

Haematuria (presence of blood in urine): 15 people, 57.69%
Urination - Painful: 9 people, 34.62%
Urinary Tract Infection: 9 people, 34.62%
Enlarged Prostate: 8 people, 30.77%
Bleeding Disorders: 8 people, 30.77%
Urinary Retention (the inability to completely or partially empty the bladder): 8 people, 30.77%
Bladder Dilatation: 8 people, 30.77%
Kidney Stones: 8 people, 30.77%
Unilateral Hydronephrosis (kidney stone that causes obstruction of the ureter): 8 people, 30.77%
Weakness: 6 people, 23.08%

What are the existing conditions these people have? *

Stroke (sudden death of a portion of the brain cells due to a lack of oxygen): 8 people, 30.77%
High Blood Pressure: 7 people, 26.92%
Diabetes: 7 people, 26.92%
Prostate Cancer: 4 people, 15.38%
Urinary Tract Disorder: 2 people, 7.69%
High Blood Cholesterol: 2 people, 7.69%
Depression: 2 people, 7.69%
Cardiac Disorder: 2 people, 7.69%
Macular Degeneration (painless eye condition that leads to the gradual loss of central vision): 1 person, 3.85%

* Approximation only. Some reports may have incomplete information.

Do you take Pradaxa and have Calculus bladder?

- Check whether Calculus bladder 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 Calculus bladder:

Calculus bladder (209 drugs)

Browse all the conditions that are associated with Calculus bladder:

Calculus bladder (621 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.