Pradaxa and Proctitis - a phase IV clinical study of FDA data

Summary:

Proctitis is reported as a side effect among people who take Pradaxa (dabigatran etexilate mesylate), especially for people who are female, 60+ old, have been taking the drug for 1 - 2 years also take Amlodipine, and have Asthma.

The phase IV clinical study analyzes which people have Proctitis 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 Proctitis?

Proctitis (inflammation of the rectum and anus) is found to be associated with 461 drugs and 618 conditions by eHealthMe. Check the latest studies of Proctitis.

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, 29, 2026

86,033 people reported to have side effects when taking Pradaxa.
Among them, 28 people (0.03%) have Proctitis.

Among these 28 people:

How long have people been on Pradaxa when they have Proctitis? *

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

female: 74.07 %
male: 25.93 %

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

What are other drugs people take besides Pradaxa? *

What are other side effects people have besides Proctitis? *

Haemorrhoids (a swollen vein or group of veins in the region of the anus): 20 people, 71.43%
Hypersensitivity: 17 people, 60.71%
Spinal Osteoarthritis (joint cartilage loss in spine): 17 people, 60.71%
Enlarged Heart: 17 people, 60.71%
Renal Cyst (kidney cyst): 17 people, 60.71%
Haematochezia (passage of stools containing blood): 17 people, 60.71%
Intestinal Haemorrhage (bleeding from intestine): 17 people, 60.71%
Dyspnea Exertional: 17 people, 60.71%
Hepatic Steatosis (fatty liver disease): 17 people, 60.71%
Hyperuricaemia (level of uric acid in the blood that is abnormally high): 17 people, 60.71%

What are the existing conditions these people have? *

Asthma: 12 people, 42.86%
Tinnitus (a ringing in the ears): 6 people, 21.43%
Pharyngitis (inflammation of the pharynx, causing a sore throat): 6 people, 21.43%
Oropharyngeal Pain: 6 people, 21.43%
Itching: 6 people, 21.43%
Ventricular Extrasystoles (premature cardiac contraction): 1 person, 3.57%
Prostate Cancer: 1 person, 3.57%
High Blood Pressure: 1 person, 3.57%
High Blood Cholesterol: 1 person, 3.57%
Dyslipidaemia (abnormal amount of lipids): 1 person, 3.57%

* Approximation only. Some reports may have incomplete information.

Do you take Pradaxa and have Proctitis?

- Check whether Proctitis 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)

Proctitis treatments and more:

Proctitis (4,383 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 Proctitis:

Proctitis (461 drugs)

Browse all the conditions that are associated with Proctitis:

Proctitis (618 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.