Harvoni and Gastric ulcer - a phase IV clinical study of FDA data

Summary:

Gastric ulcer is reported as a side effect among people who take Harvoni (ledipasvir; sofosbuvir), especially for people who are male, 60+ old, have been taking the drug for 1 - 6 months also take Lantus, and have Hepatitis c.

The phase IV clinical study analyzes which people have Gastric ulcer when taking Harvoni. It is created by eHealthMe based on reports of 19,802 people who have side effects when taking Harvoni from the FDA, and is updated regularly.

What is Harvoni?

Harvoni has active ingredients of ledipasvir; sofosbuvir. eHealthMe is studying from 19,858 Harvoni users. Check the latest studies of Harvoni.

What is Gastric ulcer?

Gastric ulcer (stomach ulcer) is found to be associated with 1,956 drugs and 3,381 conditions by eHealthMe. Check the latest studies of Gastric ulcer.

On Jul, 14, 2026

19,802 people reported to have side effects when taking Harvoni.
Among them, 23 people (0.12%) have Gastric ulcer.

Among these 23 people:

How long have people been on Harvoni when they have Gastric ulcer? *

What is the gender of people who have Gastric ulcer when taking Harvoni? *

female: 39.13 %
male: 60.87 %

What is the age of people who have Gastric ulcer when taking Harvoni? *

What are other drugs people take besides Harvoni? *

What are other side effects people have besides Gastric ulcer? *

Anaemia (lack of blood): 4 people, 17.39%
Duodenal Ulcer Haemorrhage (bleeding duodenal ulcer): 3 people, 13.04%
Varices Oesophageal (enlarged and swollen veins at the bottom of the oesophagus, near the stomach): 3 people, 13.04%
Headache (pain in head): 3 people, 13.04%
Gastrointestinal Haemorrhage (bleeding gastrointestinal tract): 3 people, 13.04%
Faeces Discolored: 3 people, 13.04%
Pain In Extremity: 2 people, 8.70%
Hepatocellular Carcinoma (liver cancer): 2 people, 8.70%
Insomnia (sleeplessness): 2 people, 8.70%
Gastrointestinal Disorder (functional problems of gastrointestinal tract): 2 people, 8.70%

What are the existing conditions these people have? *

Hepatitis C: 11 people, 47.83%
Stable Angina (a constant chest pain): 1 person, 4.35%
Portal Hypertension (increase in the blood pressure within a system of veins called the portal venous system): 1 person, 4.35%
Pancreatic Insufficiency: 1 person, 4.35%
High Blood Pressure: 1 person, 4.35%
Fluid Retention (an abnormal accumulation of fluid in the blood): 1 person, 4.35%
Atrial Fibrillation/flutter (atrial fibrillation and flutter are abnormal heart rhythms in which the atria, or upper chambers of the heart, are out of sync with the ventricles): 1 person, 4.35%
Anaemia (lack of blood): 1 person, 4.35%

* Approximation only. Some reports may have incomplete information.

Do you take Harvoni and have Gastric ulcer?

- Check whether Gastric ulcer 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 Harvoni:

Harvoni (19,858 reports)

Gastric ulcer treatments and more:

Gastric ulcer (113,573 reports)

Browse all side effects of Harvoni:

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 Gastric ulcer:

Gastric ulcer (1,956 drugs)

Browse all the conditions that are associated with Gastric ulcer:

Gastric ulcer (3,381 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on ledipasvir; sofosbuvir (the active ingredients of Harvoni) and Harvoni (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.