Sudafed and Stomatitis - a phase IV clinical study of FDA data

Summary:

Stomatitis is reported as a side effect among people who take Sudafed (pseudoephedrine hydrochloride), especially for people who are female, 50-59 old, have been taking the drug for 1 - 6 months also take Ambien, and have Systemic lupus erythematosus.

The phase IV clinical study analyzes which people have Stomatitis when taking Sudafed. It is created by eHealthMe based on reports of 11,196 people who have side effects when taking Sudafed from the FDA, and is updated regularly.

What is Sudafed?

Sudafed has active ingredients of pseudoephedrine hydrochloride. It is often used in nasal congestion. eHealthMe is studying from 12,944 Sudafed users. Check the latest studies of Sudafed.

What is Stomatitis?

Stomatitis (inflammation of mucous membrane of mouth) is found to be associated with 1,883 drugs and 2,011 conditions by eHealthMe. Check the latest studies of Stomatitis.

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, 27, 2026

11,196 people reported to have side effects when taking Sudafed.
Among them, 59 people (0.53%) have Stomatitis.

Among these 59 people:

How long have people been on Sudafed when they have Stomatitis? *

What is the gender of people who have Stomatitis when taking Sudafed? *

female: 77.19 %
male: 22.81 %

What is the age of people who have Stomatitis when taking Sudafed? *

What are other drugs people take besides Sudafed? *

What are other side effects people have besides Stomatitis? *

Diarrhea: 39 people, 66.10%
Fatigue (feeling of tiredness): 37 people, 62.71%
Pain: 28 people, 47.46%
Swelling: 27 people, 45.76%
Bone Pain: 27 people, 45.76%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 27 people, 45.76%
Nausea (feeling of having an urge to vomit): 26 people, 44.07%
Sinusitis (inflammation of sinus): 26 people, 44.07%
Pain In Jaw: 26 people, 44.07%
Pneumonia: 26 people, 44.07%

What are the existing conditions these people have? *

Osteoporosis (bones weak and more likely to break): 24 people, 40.68%
Systemic Lupus Erythematosus (an autoimmune disease, which means the body's immune system mistakenly, attacks healthy tissue): 24 people, 40.68%
Thrombocytopenia (decrease of platelets in blood): 11 people, 18.64%
Nausea (feeling of having an urge to vomit): 5 people, 8.47%
Stress And Anxiety: 4 people, 6.78%
Breast Cancer Female: 3 people, 5.08%
Multiple Myeloma (cancer of the plasma cells): 3 people, 5.08%
Pain: 3 people, 5.08%
Eczema (patches of skin become rough and inflamed, with itching and bleeding blisters): 2 people, 3.39%
Mucosal Inflammation (infection of mucous membrane): 2 people, 3.39%

* Approximation only. Some reports may have incomplete information.

Do you take Sudafed and have Stomatitis?

- Check whether 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 Sudafed:

Sudafed (12,944 reports)

Stomatitis treatments and more:

Stomatitis (75,938 reports)

Browse all side effects of Sudafed:

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 Stomatitis:

Stomatitis (1,883 drugs)

Browse all the conditions that are associated with Stomatitis:

Stomatitis (2,011 conditions)

How the study uses the data?

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