Opsumit and Brain oedema - a phase IV clinical study of FDA data

Summary:

Brain oedema 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 month also take Adcirca, and have Primary pulmonary hypertension.

The phase IV clinical study analyzes which people have Brain oedema 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 Brain oedema?

Brain oedema (excess accumulation of fluid in the intracellular or extracellular spaces of the brain) is found to be associated with 958 drugs and 1,253 conditions by eHealthMe. Check the latest studies of Brain oedema.

On Jul, 27, 2026

67,913 people reported to have side effects when taking Opsumit.
Among them, 14 people (0.02%) have Brain oedema.

Among these 14 people:

How long have people been on Opsumit when they have Brain oedema? *

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

female: 78.57 %
male: 21.43 %

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

What are other drugs people take besides Opsumit? *

What are other side effects people have besides Brain oedema? *

Pulmonary Oedema (fluid accumulation in the lungs): 4 people, 28.57%
Pneumonia: 4 people, 28.57%
Fatigue (feeling of tiredness): 3 people, 21.43%
Fall: 3 people, 21.43%
Fainting (loss of consciousness and postural tone): 3 people, 21.43%
Dyspnea (difficult or laboured breathing): 3 people, 21.43%
Dizziness: 3 people, 21.43%
Mental Status Changes (general changes in brain function, such as confusion, amnesia (memory loss), loss of alertness, loss of orientation): 3 people, 21.43%
Consciousness - Decreased: 3 people, 21.43%
Cerebral Haemorrhage (bleeding within the brain): 3 people, 21.43%

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): 9 people, 64.29%
Pulmonary Hypertension (increase in blood pressure in the lung artery): 4 people, 28.57%
Systemic Lupus Erythematosus (an autoimmune disease, which means the body's immune system mistakenly, attacks healthy tissue): 1 person, 7.14%

* Approximation only. Some reports may have incomplete information.

Do you take Opsumit and have Brain oedema?

- Check whether Brain oedema 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)

Brain oedema treatments and more:

Brain oedema (16,340 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 Brain oedema:

Brain oedema (959 drugs)

Browse all the conditions that are associated with Brain oedema:

Brain oedema (1,253 conditions)

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.