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

Summary:

Gallstones 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 Fish Oil, and have Idiopathic pulmonary fibrosis.

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

Gallstones (stone formation by bile component) is found to be associated with 1,815 drugs and 2,097 conditions by eHealthMe. Check the latest studies of Gallstones.

On Jul, 19, 2026

24,754 people reported to have side effects when taking Ofev.
Among them, 92 people (0.37%) have Gallstones.

Among these 92 people:

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

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

female: 41.57 %
male: 58.43 %

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

What are other drugs people take besides Ofev? *

What are other side effects people have besides Gallstones? *

Diarrhea: 55 people, 59.78%
Nausea (feeling of having an urge to vomit): 41 people, 44.57%
Fatigue (feeling of tiredness): 40 people, 43.48%
Weight Decreased: 32 people, 34.78%
Appetite - Decreased (decreased appetite occurs when you have a reduced desire to eat): 30 people, 32.61%
Dyspnea (difficult or laboured breathing): 29 people, 31.52%
Abdominal Pain: 24 people, 26.09%
Abdominal Discomfort: 23 people, 25.00%
Nausea And Vomiting: 23 people, 25.00%
Weakness: 23 people, 25.00%

What are the existing conditions these people have? *

Idiopathic Pulmonary Fibrosis (chronic lung disease): 79 people, 85.87%
Interstitial Lung Disease: 14 people, 15.22%
High Blood Pressure: 4 people, 4.35%
Hyperlipidaemia (presence of excess lipids in the blood): 3 people, 3.26%
Sleep Disorder: 3 people, 3.26%
Renal Disorder (kidney disease): 3 people, 3.26%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 3 people, 3.26%
High Blood Cholesterol: 2 people, 2.17%
Type 2 Diabetes: 2 people, 2.17%
Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 2 people, 2.17%

* Approximation only. Some reports may have incomplete information.

Do you take Ofev and have Gallstones?

- Check whether Gallstones 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)

Gallstones treatments and more:

Gallstones (50,126 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 Gallstones:

Gallstones (1,815 drugs)

Browse all the conditions that are associated with Gallstones:

Gallstones (2,097 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.