Opsumit and Diabetic ketoacidosis - a phase IV clinical study of FDA data


We study 62,758 people who have side effects when taking Opsumit. Diabetic ketoacidosis is found, especially among people who are male, 40-49 old, have been taking the drug for 2 - 5 years, also take Uptravi and have Primary pulmonary hypertension.

The phase IV clinical study analyzes which people take Opsumit and have Diabetic ketoacidosis. It is created by eHealthMe based on reports from the FDA, and is updated regularly. You may use the study as a second opinion to make health care decisions.

Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. Our original studies have been referenced on 700+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Sep, 28, 2023

62,758 people reported to have side effects when taking Opsumit.
Among them, 14 people (0.02%) have Diabetic ketoacidosis.

What is Opsumit?

Opsumit has active ingredients of macitentan. Currently, eHealthMe is studying from 62,771 Opsumit users.

What is Diabetic ketoacidosis?

Diabetic ketoacidosis (diabetic ketoacidosis (dka) is high concentrations of ketone bodies) is found to be associated with 2,115 drugs and 1,689 conditions by eHealthMe. Currently, we are studying 36,451 people who have Diabetic ketoacidosis.

Number of Opsumit and Diabetic ketoacidosis reports submitted per year:

Could Opsumit cause Diabetic ketoacidosis?

Time on Opsumit when people have Diabetic ketoacidosis *:

  • < 1 month: 0.0 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 100 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Diabetic ketoacidosis when taking Opsumit *:

  • female: 42.86 %
  • male: 57.14 %

Age of people who have Diabetic ketoacidosis when taking Opsumit *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 53.85 %
  • 50-59: 15.38 %
  • 60+: 30.77 %

Common drugs people take besides Opsumit *:

  1. Uptravi: 5 people, 35.71%
  2. Remodulin: 4 people, 28.57%
  3. Januvia: 4 people, 28.57%
  4. Ventolin Hfa: 3 people, 21.43%
  5. Adempas: 3 people, 21.43%
  6. Tyvaso: 1 person, 7.14%
  7. Treprostinil: 1 person, 7.14%
  8. Sildenafil Citrate: 1 person, 7.14%
  9. Revatio: 1 person, 7.14%
  10. Orenitram: 1 person, 7.14%

Common side effects people have besides Diabetic ketoacidosis *:

  1. Nausea (feeling of having an urge to vomit): 7 people, 50.00%
  2. Bone Pain: 5 people, 35.71%
  3. Diarrhea: 5 people, 35.71%
  4. Joint Pain: 5 people, 35.71%
  5. Pain In Jaw: 5 people, 35.71%
  6. Pain In Extremity: 5 people, 35.71%
  7. Type 2 Diabetes: 4 people, 28.57%
  8. 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): 4 people, 28.57%
  9. Blood Glucose Increased: 4 people, 28.57%
  10. Malaise (a feeling of general discomfort or uneasiness): 4 people, 28.57%

Common conditions people have *:

  1. Primary Pulmonary Hypertension (primary high blood pressure that affects the arteries in the lungs and the right side of your heart): 12 people, 85.71%
  2. Pulmonary Hypertension (increase in blood pressure in the lung artery): 3 people, 21.43%

* Approximation only. Some reports may have incomplete information.

Do you take Opsumit and have Diabetic ketoacidosis?

Check whether Diabetic ketoacidosis is associated with a drug or a condition

How to use the study?

You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood.

Related studies

Opsumit side effects by duration, gender and age:

Diabetic ketoacidosis treatments and more:

Common drugs associated with Diabetic ketoacidosis:

All the drugs that are associated with Diabetic ketoacidosis:

Common conditions associated with Diabetic ketoacidosis:

All the conditions that are associated with Diabetic ketoacidosis:

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.

Who is eHealthMe?

With medical big data and proven AI 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 700+ 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: 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.

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