Harvoni and Pleural effusion - a phase IV clinical study of FDA data

Summary:

Pleural effusion 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 Lasix, and have Hepatitis c.

The phase IV clinical study analyzes which people have Pleural effusion 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 Pleural effusion?

Pleural effusion (water on the lungs) is found to be associated with 2,219 drugs and 3,150 conditions by eHealthMe. Check the latest studies of Pleural effusion.

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

19,802 people reported to have side effects when taking Harvoni.
Among them, 32 people (0.16%) have Pleural effusion.

Among these 32 people:

How long have people been on Harvoni when they have Pleural effusion? *

What is the gender of people who have Pleural effusion when taking Harvoni? *

female: 46.67 %
male: 53.33 %

What is the age of people who have Pleural effusion when taking Harvoni? *

What are other drugs people take besides Harvoni? *

What are other side effects people have besides Pleural effusion? *

Ascites (accumulation of fluid in the abdominal cavity): 11 people, 34.38%
Fever: 5 people, 15.62%
Weight Increased: 3 people, 9.38%
Cardiac Failure: 3 people, 9.38%
Fatigue (feeling of tiredness): 3 people, 9.38%
Diarrhea: 3 people, 9.38%
Blood Uric Acid Increased: 2 people, 6.25%
Cough: 2 people, 6.25%
Electrocardiogram Abnormal: 2 people, 6.25%
Infection Susceptibility Increased: 2 people, 6.25%

What are the existing conditions these people have? *

Hepatitis C: 16 people, 50.00%
Constipation: 3 people, 9.38%
High Blood Pressure: 3 people, 9.38%
Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 2 people, 6.25%
Hepatic Cirrhosis (chronic liver disease characterized by replacement of liver tissue by fibrosis, scar tissue): 2 people, 6.25%
Type 2 Diabetes: 1 person, 3.12%
Gastritis (inflammation of stomach): 1 person, 3.12%
Arrhythmias (irregular heartbeat): 1 person, 3.12%
Ascites (accumulation of fluid in the abdominal cavity): 1 person, 3.12%
Carotid Artery Stenosis (narrowing of carotid artery): 1 person, 3.12%

* Approximation only. Some reports may have incomplete information.

Do you take Harvoni and have Pleural effusion?

- Check whether Pleural effusion is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
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Related studies:

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

Harvoni (19,858 reports)

Pleural effusion treatments and more:

Pleural effusion (84,634 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 Pleural effusion:

Pleural effusion (2,219 drugs)

Browse all the conditions that are associated with Pleural effusion:

Pleural effusion (3,150 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.