Opsumit and Myositis - a phase IV clinical study of FDA data

Summary:

Myositis is reported as a side effect among people who take Opsumit (macitentan), especially for people who are female, 60+ old, have been taking the drug for 1 - 2 years also take Adcirca, and have Primary pulmonary hypertension.

The phase IV clinical study analyzes which people have Myositis when taking Opsumit. It is created by eHealthMe based on reports of 67,913 people who have side effects when taking Opsumit from the FDA, and is updated regularly.

What is Opsumit?

Opsumit has active ingredients of macitentan. eHealthMe is studying from 67,926 Opsumit users. Check the latest studies of Opsumit.

What is Myositis?

Myositis (inflammation of the muscles) is found to be associated with 827 drugs and 1,137 conditions by eHealthMe. Check the latest studies of Myositis.

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 Jul, 28, 2026

67,913 people reported to have side effects when taking Opsumit.
Among them, 12 people (0.02%) have Myositis.

Among these 12 people:

How long have people been on Opsumit when they have Myositis? *

What is the gender of people who have Myositis when taking Opsumit? *

female: 100 %
male: 0.0 %

What is the age of people who have Myositis when taking Opsumit? *

What are other drugs people take besides Opsumit? *

What are other side effects people have besides Myositis? *

Dyspnea (difficult or laboured breathing): 8 people, 66.67%
Glomerular Filtration Rate Decreased: 7 people, 58.33%
Pleural Effusion (water on the lungs): 7 people, 58.33%
Cardiac Failure: 7 people, 58.33%
Blood Creatinine Increased: 7 people, 58.33%
Creatinine Renal Clearance Decreased: 7 people, 58.33%
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): 7 people, 58.33%
Arrhythmias (irregular heartbeat): 7 people, 58.33%
Renal Impairment (severely reduced kidney function): 7 people, 58.33%
Right Ventricular Failure (right half of the heart fails to work): 7 people, 58.33%

What are the existing conditions these people have? *

Primary Pulmonary Hypertension (primary high blood pressure that affects the arteries in the lungs and the right side of your heart): 11 people, 91.67%
Vitamin B Complex Deficiency: 7 people, 58.33%
Rickets (softening of bones): 7 people, 58.33%
Hypovitaminosis (any of several diseases caused by deficiency of one or more vitamins): 7 people, 58.33%
Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 7 people, 58.33%
Gastritis (inflammation of stomach): 7 people, 58.33%
Cardiac Failure: 7 people, 58.33%
Arrhythmias (irregular heartbeat): 7 people, 58.33%
Pulmonary Hypertension (increase in blood pressure in the lung artery): 1 person, 8.33%
Connective Tissue Disorder (any disease that has the connective tissues of the body): 1 person, 8.33%

* Approximation only. Some reports may have incomplete information.

Do you take Opsumit and have Myositis?

- Check whether Myositis 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 Opsumit:

Opsumit (67,926 reports)

Myositis treatments and more:

Myositis (13,181 reports)

Browse all side effects of Opsumit:

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 Myositis:

Myositis (827 drugs)

Browse all the conditions that are associated with Myositis:

Myositis (1,137 conditions)

Related publications that referenced our studies

Proti? D, Balti? S, Stupar N, Pavlov-Dolijanovi? S, Mugo?a S, Todorovi? Z, "A case of myositis with immunological background associated with statin use", Open Medicine, 2014 Oct .
Proti? D, Balti? S, Stupar N, Pavlov-Dolijanovi? S, Mugo?a S, Todorovi? Z, "A case of myositis with immunological background associated with statin use", Open Medicine, 2014 Oct .

How the study uses the data?

The study uses data from the FDA. It is based on macitentan (the active ingredients of Opsumit) and Opsumit (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.