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

Summary:

Tinnitus 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 Tinnitus 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 Tinnitus?

Tinnitus (a ringing in the ears) is found to be associated with 1,668 drugs and 3,065 conditions by eHealthMe. Check the latest studies of Tinnitus.

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

67,913 people reported to have side effects when taking Opsumit.
Among them, 204 people (0.3%) have Tinnitus.

Among these 204 people:

* Approximation only. Some reports may have incomplete information.

Do you take Opsumit and have Tinnitus?

- Check whether Tinnitus 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)

Tinnitus treatments and more:

Tinnitus (58,554 reports)

How severe was Tinnitus and when was it recovered:

Tinnitus in Opsumit

Expand to all the drugs that have ingredients of macitentan:

Tinnitus and drugs with ingredients of macitentan (214 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 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 Tinnitus:

Tinnitus (1,668 drugs)

Browse all the conditions that are associated with Tinnitus:

Tinnitus (3,065 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.