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

Summary:

Death is reported as a side effect among people who take Olysio (simeprevir), especially for people who are female, 60+ old, have been taking the drug for 1 - 6 months also take Sovaldi, and have Hepatitis c.

The study is created by eHealthMe based on reports of 3,074 people who have side effects when taking Olysio from the FDA, and is updated regularly.

What is Olysio?

Olysio has active ingredients of simeprevir. eHealthMe is studying from 3,076 Olysio users. Check the latest studies of Olysio.

On Jul, 22, 2026

3,074 people reported to have side effects when taking Olysio.
Among them, 68 people (2.21%) died.

Among these 68 people:

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

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

female: 54.24 %
male: 45.76 %

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

What are other drugs people take besides Olysio? *

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

Hepatic Failure (liver failure): 5 people, 7.35%
Weakness: 4 people, 5.88%
Jaundice - Yellow Skin (a yellowish pigmentation of the skin): 4 people, 5.88%
Back Pain: 3 people, 4.41%
Hypotension (abnormally low blood pressure): 3 people, 4.41%
Diarrhea: 3 people, 4.41%
Rectal Haemorrhage (bleeding from anus): 3 people, 4.41%
Fatigue (feeling of tiredness): 3 people, 4.41%
Dehydration (dryness resulting from the removal of water): 3 people, 4.41%
Consciousness - Decreased: 3 people, 4.41%

What are the existing conditions these people have? *

Hepatitis C: 32 people, 47.06%
Hepatitis C Antibody Positive: 5 people, 7.35%
Diabetes: 5 people, 7.35%
High Blood Pressure: 5 people, 7.35%
Hepatic Cirrhosis (chronic liver disease characterized by replacement of liver tissue by fibrosis, scar tissue): 3 people, 4.41%
Depression: 3 people, 4.41%
Schizophrenia (a mental disorder characterized by a breakdown of thought processes): 3 people, 4.41%
Portal Hypertension (increase in the blood pressure within a system of veins called the portal venous system): 3 people, 4.41%
Type 1 Diabetes: 3 people, 4.41%
Cardiac Failure: 3 people, 4.41%

* Approximation only. Some reports may have incomplete information.

Related studies:

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

Olysio (3,076 reports)

Expand to all the drugs that have ingredients of simeprevir:

Death and drugs with ingredients of simeprevir (74 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 Olysio:

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 (3,124 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 simeprevir (the active ingredients of Olysio) and Olysio (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.