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

Summary:

Mouth ulcers is reported as a side effect among people who take Benlysta (belimumab), especially for people who are female, 50-59 old, have been taking the drug for 1 - 6 months also take Plaquenil, and have Inflammation.

The phase IV clinical study analyzes which people have Mouth ulcers when taking Benlysta. It is created by eHealthMe based on reports of 23,452 people who have side effects when taking Benlysta from the FDA, and is updated regularly.

What is Benlysta?

Benlysta has active ingredients of belimumab. It is often used in systemic lupus erythematosus. eHealthMe is studying from 23,528 Benlysta users. Check the latest studies of Benlysta.

What is Mouth ulcers?

Mouth ulcers is found to be associated with 1,328 drugs and 2,175 conditions by eHealthMe. Check the latest studies of Mouth ulcers.

On Jul, 17, 2026

23,452 people reported to have side effects when taking Benlysta.
Among them, 53 people (0.23%) have Mouth ulcers.

Could Benlysta cause Mouth ulcers?

Among these 53 people:

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

  • < 1 month: 22.22 %
  • 1 - 6 months: 44.44 %
  • 6 - 12 months: 22.22 %
  • 1 - 2 years: 11.11 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

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

  • female: 97.87 %
  • male: 2.13 %

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

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 5.13 %
  • 20-29: 12.82 %
  • 30-39: 20.51 %
  • 40-49: 12.82 %
  • 50-59: 41.03 %
  • 60+: 7.69 %

What are other drugs people take besides Benlysta? *

  1. Plaquenil: 15 people, 28.30%
  2. Prednisone: 5 people, 9.43%
  3. Methotrexate: 3 people, 5.66%
  4. Azathioprine: 3 people, 5.66%
  5. Tylenol: 3 people, 5.66%
  6. Cellcept: 3 people, 5.66%
  7. Cozaar: 2 people, 3.77%
  8. Macrobid: 2 people, 3.77%
  9. Medrol: 2 people, 3.77%
  10. Imuran: 2 people, 3.77%

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

  1. Fatigue (feeling of tiredness): 24 people, 45.28%
  2. Fever: 18 people, 33.96%
  3. Rashes (redness): 16 people, 30.19%
  4. Joint Pain: 14 people, 26.42%
  5. Weight Decreased: 11 people, 20.75%
  6. Nausea (feeling of having an urge to vomit): 11 people, 20.75%
  7. Hair Loss: 11 people, 20.75%
  8. Pneumonia: 11 people, 20.75%
  9. Pain: 10 people, 18.87%
  10. Malaise (a feeling of general discomfort or uneasiness): 9 people, 16.98%

What are the existing conditions these people have? *

  1. Pain: 2 people, 3.77%
  2. Osteoarthritis (a joint disease caused by cartilage loss in a joint): 2 people, 3.77%
  3. Inflammation: 2 people, 3.77%
  4. Streptococcal Infection: 1 person, 1.89%
  5. Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 1 person, 1.89%
  6. Oropharyngeal Pain: 1 person, 1.89%
  7. Oral Pain: 1 person, 1.89%
  8. Immunodeficiency Disorders: 1 person, 1.89%
  9. Chest Pain: 1 person, 1.89%

* Approximation only. Some reports may have incomplete information.

Do you take Benlysta 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 Benlysta:

Mouth ulcers treatments and more:

How severe was Mouth ulcers and when was it recovered:

Expand to all the drugs that have ingredients of belimumab:

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Benlysta:

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:

Browse all the conditions that are associated with Mouth ulcers:

How the study uses the data?

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

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