Opsumit and Renal haemorrhage - a phase IV clinical study of FDA data

Summary:

Renal haemorrhage 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 Remodulin, and have Primary pulmonary hypertension.

The phase IV clinical study analyzes which people have Renal haemorrhage 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 Renal haemorrhage?

Renal haemorrhage (bleeding from kidney) is found to be associated with 326 drugs and 397 conditions by eHealthMe. Check the latest studies of Renal haemorrhage.

On Jul, 27, 2026

67,913 people reported to have side effects when taking Opsumit.
Among them, 11 people (0.02%) have Renal haemorrhage.

Among these 11 people:

How long have people been on Opsumit when they have Renal haemorrhage? *

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

female: 72.73 %
male: 27.27 %

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

What are other drugs people take besides Opsumit? *

What are other side effects people have besides Renal haemorrhage? *

Hypotension (abnormally low blood pressure): 8 people, 72.73%
Dizziness: 8 people, 72.73%
Dyspnea (difficult or laboured breathing): 6 people, 54.55%
Arrhythmias (irregular heartbeat): 5 people, 45.45%
Urinary Tract Infection: 5 people, 45.45%
Infusion Site Erythema (reddening of the skin at infusion site): 4 people, 36.36%
Hypervolaemia (abnormally increased volume of blood): 4 people, 36.36%
Infusion Site Discomfort: 4 people, 36.36%
Heart Rate Increased: 4 people, 36.36%
Infusion Site Pain: 4 people, 36.36%

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): 10 people, 90.91%
Systemic Lupus Erythematosus (an autoimmune disease, which means the body's immune system mistakenly, attacks healthy tissue): 1 person, 9.09%

* Approximation only. Some reports may have incomplete information.

Do you take Opsumit and have Renal haemorrhage?

- Check whether Renal haemorrhage 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)

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 Renal haemorrhage:

Renal haemorrhage (327 drugs)

Browse all the conditions that are associated with Renal haemorrhage:

Renal haemorrhage (397 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.