Enbrel and Kounis syndrome - a phase IV clinical study of FDA data
Summary:
Kounis syndrome is reported only by a few people who take Enbrel.
The phase IV clinical study analyzes which people take Enbrel and have Kounis syndrome. It is created by eHealthMe based on reports of 652,272 people who have side effects while taking Enbrel from the FDA, and is updated regularly.
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 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.
652,272 people reported to have side effects when taking Enbrel.
Among them, 2 people (0.0%) have Kounis syndrome.
What is Enbrel?
Enbrel has active ingredients of etanercept. It is often used in rheumatoid arthritis. eHealthMe is studying from 654,018 Enbrel users for its effectiveness, alternative drugs and more.
What is Kounis syndrome?
Kounis syndrome (the concurrence of heart pain with conditions associated with mast cell activation leads to heart muscle damage) is found to be associated with 257 drugs and 188 conditions by eHealthMe.
Number of Enbrel and Kounis syndrome reports submitted per year:

Gender of people who have Kounis syndrome when taking Enbrel *:
- female: 100 %
- male: 0.0 %
Age of people who have Kounis syndrome when taking Enbrel *:
- 0-1: 0.0 %
- 2-9: 0.0 %
- 10-19: 0.0 %
- 20-29: 0.0 %
- 30-39: 0.0 %
- 40-49: 0.0 %
- 50-59: 50 %
- 60+: 50 %
Common drugs people take besides Enbrel *:
- Theophylline: 1 person, 50.00%
- Synthroid: 1 person, 50.00%
- Phenytoin: 1 person, 50.00%
- Methylprednisolone Sodium Succinate: 1 person, 50.00%
- Losartan Potassium: 1 person, 50.00%
- Furosemide: 1 person, 50.00%
- Cefaclor: 1 person, 50.00%
Common side effects people have besides Kounis syndrome *:
- Tremor (trembling or shaking movements in one or more parts of your body): 1 person, 50.00%
- Rash Pruritic (redness with itching): 1 person, 50.00%
- Rash Erythematous (redness of the skin): 1 person, 50.00%
- Pruritus Generalised (generalized itching): 1 person, 50.00%
- Pneumonia: 1 person, 50.00%
- Oedema Peripheral (superficial swelling): 1 person, 50.00%
- Joint Pain: 1 person, 50.00%
- Injection Site Swelling: 1 person, 50.00%
- Injection Site Pruritus (severe itching at injection site): 1 person, 50.00%
- Injection Site Erythema (redness at injection site): 1 person, 50.00%
Common conditions people have *:
- Pneumonia: 1 person, 50.00%
- Pharyngitis (inflammation of the pharynx, causing a sore throat): 1 person, 50.00%
* Approximation only. Some reports may have incomplete information.
Do you take Enbrel and have Kounis syndrome?
Check whether Kounis syndrome is associated with a drug or a conditionHow 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
How severe was Kounis syndrome and when was it recovered:
Expand to all the drugs that have ingredients of etanercept:
Alternative drugs to, pros and cons of Enbrel:
- Enbrel (654,018 reports)
Common Enbrel side effects:
- Drug ineffective: 90,931 reports
- Rheumatoid arthritis (a chronic progressive disease causing inflammation in the joints): 56,708 reports
- Joint pain: 49,616 reports
- Pain: 47,830 reports
- Fatigue (feeling of tiredness): 32,388 reports
- Rashes (redness): 29,304 reports
Browse all side effects of Enbrel:
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 zKounis syndrome treatments and more:
- Kounis syndrome (2,015 reports)
COVID vaccines that are related to Kounis syndrome:
- Kounis syndrome in Moderna COVID Vaccine
- Kounis syndrome in Pfizer BioNTech Covid Vaccine
- Kounis syndrome in Johnson and Johnson Covid Vaccine
Common drugs associated with Kounis syndrome:
- Profen: 172 reports
- Ibu: 172 reports
- Ibuprofen: 172 reports
- Clopidogrel: 101 reports
All the drugs that are associated with Kounis syndrome:
- Kounis syndrome (257 drugs)
All the conditions that are associated with Kounis syndrome:
- Kounis syndrome (188 conditions)
How the study uses the data?
The study uses data from the FDA. It is based on etanercept (the active ingredients of Enbrel) and Enbrel (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 600+ 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.
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