Ofev and Death - a phase IV clinical study of FDA data

Summary:

Death is reported as a side effect among people who take Ofev (nintedanib esylate), especially for people who are male, 60+ old, have been taking the drug for 1 - 6 months also take Tyvaso, and have Idiopathic pulmonary fibrosis.

The study 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 24,790 Ofev users. Check the latest studies of Ofev.

On Feb, 07, 2026

24,754 people reported to have side effects when taking Ofev.
Among them, 2,076 people (8.39%) died.

Among these 2,076 people:

* Approximation only. Some reports may have incomplete information.

Related studies:

Effectiveness of, long term effects of, and alternative drugs to Ofev:

Ofev (24,790 reports)

Expand to all the drugs that have ingredients of nintedanib esylate:

Death and drugs with ingredients of nintedanib esylate (2,149 reports)

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 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 Death:

Death (3,159 drugs)

Browse all the conditions that are associated with Death:

Death (3,686 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.

Ofev and Death - a phase IV clinical study of FDA data

Summary:

What is Ofev?

Among these 2,076 people:

How long have people been on Ofev when they died? *

What is the gender of people who died when taking Ofev? *

What is the age of people who died when taking Ofev? *

What are other drugs people take besides Ofev? *

What are other side effects people have before they died? *

What are the existing conditions these people have? *