Hydramine and Kounis syndrome - a phase IV clinical study of FDA data

Summary:

Kounis syndrome is reported as a side effect among people who take Hydramine (diphenhydramine hydrochloride), especially for people who are male, 60+ old, also take Epinephrine, and have Hypotension.

The phase IV clinical study analyzes which people have Kounis syndrome when taking Hydramine. It is created by eHealthMe based on reports of 113,450 people who have side effects when taking Hydramine from the FDA, and is updated regularly.

What is Hydramine?

Hydramine has active ingredients of diphenhydramine hydrochloride. It is often used in insomnia. eHealthMe is studying from 114,900 Hydramine users. Check the latest studies of Hydramine.

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 122 drugs and 203 conditions by eHealthMe. Check the latest studies of Kounis syndrome.

On Jul, 13, 2026

113,450 people reported to have side effects when taking Hydramine.
Among them, 36 people (0.03%) have Kounis syndrome.

Among these 36 people:

What is the gender of people who have Kounis syndrome when taking Hydramine? *

female: 44.44 %
male: 55.56 %

What is the age of people who have Kounis syndrome when taking Hydramine? *

What are other drugs people take besides Hydramine? *

What are other side effects people have besides Kounis syndrome? *

Anaphylaxis (serious allergic reaction that is rapid in onset and may cause death): 8 people, 22.22%
Drug Ineffective: 5 people, 13.89%
Acute Myocardial Infarction (acute heart attack): 4 people, 11.11%
Cardiac Arrest: 4 people, 11.11%
Hypotension (abnormally low blood pressure): 3 people, 8.33%
Throat Tightness: 3 people, 8.33%
Arteriospasm Coronary (spasm of the large- or medium-sized coronary arteries): 3 people, 8.33%
Swallowing Difficulty: 3 people, 8.33%
Stress Cardiomyopathy (stress-induced chronic disease of the heart muscle): 3 people, 8.33%
Sinus Disorder (disease of sinus): 3 people, 8.33%

What are the existing conditions these people have? *

Itching: 8 people, 22.22%
Hypotension (abnormally low blood pressure): 8 people, 22.22%
Anaphylaxis (serious allergic reaction that is rapid in onset and may cause death): 7 people, 19.44%
Urticaria (rash of round, red welts on the skin that itch intensely): 3 people, 8.33%
Back Pain: 3 people, 8.33%
Contrast Media Allergy (reaction associated with the use of intravenous contrast material during radiology): 3 people, 8.33%
Skin Blushing/flushing (a sudden reddening of the face, neck): 3 people, 8.33%
Nausea (feeling of having an urge to vomit): 3 people, 8.33%
Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 3 people, 8.33%
Deep Venous Thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis): 2 people, 5.56%

* Approximation only. Some reports may have incomplete information.

Do you take Hydramine and have Kounis syndrome?

- Check whether Kounis syndrome 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 Hydramine:

Hydramine (114,900 reports)

Kounis syndrome treatments and more:

Kounis syndrome (2,190 reports)

Browse all side effects of Hydramine:

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 Kounis syndrome:

Kounis syndrome (122 drugs)

Browse all the conditions that are associated with Kounis syndrome:

Kounis syndrome (203 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on diphenhydramine hydrochloride (the active ingredients of Hydramine) and Hydramine (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.