Ofev and Gastrointestinal ulcer haemorrhage - a phase IV clinical study of FDA data

Summary:

Gastrointestinal ulcer haemorrhage is reported as a side effect among people who take Ofev (nintedanib esylate), especially for people who are male, 60+ old, also take Ciprofloxacin, and have Idiopathic pulmonary fibrosis.

The phase IV clinical study analyzes which people have Gastrointestinal ulcer haemorrhage when taking Ofev. It is created by eHealthMe based on reports of 24,754 people who have side effects when taking Ofev from the FDA, and is updated regularly.

What is Ofev?

Ofev has active ingredients of nintedanib esylate. eHealthMe is studying from 24,791 Ofev users. Check the latest studies of Ofev.

What is Gastrointestinal ulcer haemorrhage?

Gastrointestinal ulcer haemorrhage (bleeding ulcer of digestive system) is found to be associated with 146 drugs and 303 conditions by eHealthMe. Check the latest studies of Gastrointestinal ulcer haemorrhage.

On Jul, 21, 2026

24,754 people reported to have side effects when taking Ofev.
Among them, 12 people (0.05%) have Gastrointestinal ulcer haemorrhage.

Could Ofev cause Gastrointestinal ulcer haemorrhage?

Among these 12 people:

What is the gender of people who have Gastrointestinal ulcer haemorrhage when taking Ofev? *

female: 41.67 %
male: 58.33 %

What is the age of people who have Gastrointestinal ulcer haemorrhage when taking Ofev? *

What are other drugs people take besides Ofev? *

What are other side effects people have besides Gastrointestinal ulcer haemorrhage? *

Diarrhea: 7 people, 58.33%
Haematemesis (vomiting of blood): 6 people, 50.00%
Procedural Pain: 4 people, 33.33%
Headache (pain in head): 4 people, 33.33%
High Blood Pressure: 4 people, 33.33%
Nausea (feeling of having an urge to vomit): 4 people, 33.33%
Spinal Stenosis (narrowing of spinal column): 4 people, 33.33%
Chest Pain: 4 people, 33.33%
Coughing Up Blood: 3 people, 25.00%
Cough: 3 people, 25.00%

What are the existing conditions these people have? *

Idiopathic Pulmonary Fibrosis (chronic lung disease): 11 people, 91.67%
Sleep Disorder: 1 person, 8.33%

* Approximation only. Some reports may have incomplete information.

Do you take Ofev and have Gastrointestinal ulcer haemorrhage?

- Check whether Gastrointestinal ulcer haemorrhage 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 Ofev:

Ofev (24,791 reports)

Browse all side effects of Ofev:

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 Gastrointestinal ulcer haemorrhage:

Gastrointestinal ulcer haemorrhage (146 drugs)

Browse all the conditions that are associated with Gastrointestinal ulcer haemorrhage:

Gastrointestinal ulcer haemorrhage (303 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on nintedanib esylate (the active ingredients of Ofev) and Ofev (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.