Soliris and Mouth ulcers - a phase IV clinical study of FDA data

Summary:

Mouth ulcers is reported as a side effect among people who take Soliris (eculizumab), especially for people who are male, 50-59 old, have been taking the drug for < 1 month also take Ciprofloxacin, and have Paroxysmal nocturnal haemoglobinuria.

The phase IV clinical study analyzes which people have Mouth ulcers when taking Soliris. It is created by eHealthMe based on reports of 58,774 people who have side effects when taking Soliris from the FDA, and is updated regularly.

What is Soliris?

Soliris has active ingredients of eculizumab. It is often used in paroxysmal nocturnal hemoglobinuria (pnh). eHealthMe is studying from 58,821 Soliris users. Check the latest studies of Soliris.

What is Mouth ulcers?

Mouth ulcers is found to be associated with 1,320 drugs and 2,176 conditions by eHealthMe. Check the latest studies of Mouth ulcers.

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 Sep, 01, 2026

58,774 people reported to have side effects when taking Soliris.
Among them, 64 people (0.11%) have Mouth ulcers.

Among these 64 people:

How long have people been on Soliris when they have Mouth ulcers? *

What is the gender of people who have Mouth ulcers when taking Soliris? *

female: 31.03 %
male: 68.97 %

What is the age of people who have Mouth ulcers when taking Soliris? *

What are other drugs people take besides Soliris? *

What are other side effects people have besides Mouth ulcers? *

Fatigue (feeling of tiredness): 28 people, 43.75%
Pain: 26 people, 40.62%
Respiratory Rate Decreased (less breathing rate/min): 19 people, 29.69%
Catheter Site Cellulitis (infection of cells near catheter): 19 people, 29.69%
Fever: 18 people, 28.12%
Catheter Site Erythema (redness of skin at catheter site): 18 people, 28.12%
Cough: 15 people, 23.44%
Pseudomonas Infection (pseudomonas infection is caused by a bacterium, pseudomonas aeruginosa): 14 people, 21.88%
The Flu (the flu is caused by an influenza virus): 14 people, 21.88%
Weakness: 14 people, 21.88%

What are the existing conditions these people have? *

Paroxysmal Nocturnal Haemoglobinuria (haemoglobin in the urine): 20 people, 31.25%
Pseudomonas Infection (pseudomonas infection is caused by a bacterium, pseudomonas aeruginosa): 19 people, 29.69%
Catheter Site Infection (infection at the site of insertion): 19 people, 29.69%
Pulmonary Embolism (blockage of the main artery of the lung): 10 people, 15.62%
Neuropathy Peripheral (surface nerve damage): 8 people, 12.50%
Haemolytic Uraemic Syndrome (blood clotting disease caused by e. coli infection, birth control pills, pneumonia, medications, and more): 6 people, 9.38%
Myasthenia Gravis (a chronic condition that causes muscles to tire and weaken easily): 4 people, 6.25%
Hypersensitivity: 2 people, 3.12%
Neuralgia (pain in one or more nerves): 2 people, 3.12%
Urinary Tract Infection: 1 person, 1.56%

* Approximation only. Some reports may have incomplete information.

Do you take Soliris and have Mouth ulcers?

- Check whether Mouth ulcers 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 Soliris:

Soliris (58,821 reports)

Mouth ulcers treatments and more:

Mouth ulcers (28,862 reports)

Browse all side effects of Soliris:

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 Mouth ulcers:

Mouth ulcers (1,320 drugs)

Browse all the conditions that are associated with Mouth ulcers:

Mouth ulcers (2,176 conditions)

How the study uses the data?

The study uses data from the FDA. It is based on eculizumab (the active ingredients of Soliris) and Soliris (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.