Atarax and Aphthous stomatitis - a phase IV clinical study of FDA data

Summary:

Aphthous stomatitis is reported as a side effect among people who take Atarax (hydroxyzine hydrochloride), especially for people who are male, 20-29 old, have been taking the drug for < 1 month also take Tracleer, and have Asthma.

The phase IV clinical study analyzes which people have Aphthous stomatitis when taking Atarax. It is created by eHealthMe based on reports of 22,841 people who have side effects when taking Atarax from the FDA, and is updated regularly.

What is Atarax?

Atarax has active ingredients of hydroxyzine hydrochloride. It is often used in stress and anxiety. eHealthMe is studying from 23,553 Atarax users. Check the latest studies of Atarax.

What is Aphthous stomatitis?

Aphthous stomatitis (mouth ulcer) is found to be associated with 428 drugs and 811 conditions by eHealthMe. Check the latest studies of Aphthous stomatitis.

On Aug, 11, 2026

22,841 people reported to have side effects when taking Atarax.
Among them, 12 people (0.05%) have Aphthous stomatitis.

Among these 12 people:

How long have people been on Atarax when they have Aphthous stomatitis? *

What is the gender of people who have Aphthous stomatitis when taking Atarax? *

female: 41.67 %
male: 58.33 %

What is the age of people who have Aphthous stomatitis when taking Atarax? *

What are other drugs people take besides Atarax? *

What are other side effects people have besides Aphthous stomatitis? *

Fever: 9 people, 75.00%
Erythema Multiforme (a type of hypersensitivity reaction): 6 people, 50.00%
Rashes (redness): 5 people, 41.67%
Oral Disorder (mouth disease): 4 people, 33.33%
Skin Disorder (skin disease): 4 people, 33.33%
Toxic Skin Eruption (skin breakdown due to toxic substance): 4 people, 33.33%
Conjunctival Disorder (conjunctival disease): 3 people, 25.00%
Conjunctivitis Infective (infection of the conjunctiva): 3 people, 25.00%
Rash Vesicular (rash with a small bubble): 3 people, 25.00%
General Physical Health Deterioration (weak health status): 3 people, 25.00%

What are the existing conditions these people have? *

Hyperthyroidism (over activity of the thyroid gland): 3 people, 25.00%
Asthma: 3 people, 25.00%
High Blood Cholesterol: 2 people, 16.67%
Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 1 person, 8.33%
Precursor T-Lymphoblastic Lymphoma/leukaemia (precursor b-cell cancer): 1 person, 8.33%
Oropharyngeal Pain: 1 person, 8.33%
Ischaemic Cardiomyopathy (weakness in the muscle of the heart due to inadequate oxygen delivery to the myocardium with coronary artery disease): 1 person, 8.33%
Ill-Defined Disorder: 1 person, 8.33%
Hepatitis C: 1 person, 8.33%
Headache (pain in head): 1 person, 8.33%

* Approximation only. Some reports may have incomplete information.

Do you take Atarax and have Aphthous stomatitis?

- Check whether Aphthous stomatitis 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 Atarax:

Atarax (23,553 reports)

Browse all side effects of Atarax:

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 Aphthous stomatitis:

Aphthous stomatitis (428 drugs)

Browse all the conditions that are associated with Aphthous stomatitis:

Aphthous stomatitis (811 conditions)

Related publications that referenced our studies

Ate? ?, Arikan MF, Kaplan M, Altay M, "Hydroxyzine induced pancytopenia and petechial rashes: a rare complication", Journal Of Contemporary Medicine, 2017 Jan .
Ate? ?, Arikan MF, Kaplan M, Altay M, "Hydroxyzine induced pancytopenia and petechial rashes: a rare complication", Journal Of Contemporary Medicine, 2017 Jan .

How the study uses the data?

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