Methotrexate and Genital ulceration - a phase IV clinical study of FDA data

Summary:

Genital ulceration is reported as a side effect among people who take Methotrexate (methotrexate sodium), especially for people who are female, 50-59 old, have been taking the drug for 1 - 6 months also take Folic Acid, and have Schizophrenia.

The phase IV clinical study analyzes which people have Genital ulceration when taking Methotrexate. It is created by eHealthMe based on reports of 599,650 people who have side effects when taking Methotrexate from the FDA, and is updated regularly.

What is Methotrexate?

Methotrexate has active ingredients of methotrexate sodium. It is often used in rheumatoid arthritis. eHealthMe is studying from 604,313 Methotrexate users. Check the latest studies of Methotrexate.

What is Genital ulceration?

Genital ulceration (ulcers on sex organ) is found to be associated with 94 drugs and 198 conditions by eHealthMe. Check the latest studies of Genital ulceration.

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, 20, 2026

599,650 people reported to have side effects when taking Methotrexate.
Among them, 78 people (0.01%) have Genital ulceration.

Could Methotrexate cause Genital ulceration?

Among these 78 people:

How long have people been on Methotrexate when they have Genital ulceration? *

What is the gender of people who have Genital ulceration when taking Methotrexate? *

female: 63.38 %
male: 36.62 %

What is the age of people who have Genital ulceration when taking Methotrexate? *

What are other drugs people take besides Methotrexate? *

What are other side effects people have besides Genital ulceration? *

Mouth Ulcers: 30 people, 38.46%
Rashes (redness): 24 people, 30.77%
Fever: 18 people, 23.08%
Oral Pain: 17 people, 21.79%
Abdominal Pain Upper: 16 people, 20.51%
Diarrhea: 16 people, 20.51%
Nausea And Vomiting: 16 people, 20.51%
Food Poisoning (poison in food): 16 people, 20.51%
Mucosal Inflammation (infection of mucous membrane): 16 people, 20.51%
Inflammation: 16 people, 20.51%

What are the existing conditions these people have? *

Abdominal Discomfort: 15 people, 19.23%
Pituitary Tumor: 15 people, 19.23%
Depression: 15 people, 19.23%
Empty Sella Syndrome (pituitary gland shrinks or becomes flattened): 15 people, 19.23%
Schizophrenia (a mental disorder characterized by a breakdown of thought processes): 15 people, 19.23%
Psoriasis (immune-mediated disease that affects the skin): 14 people, 17.95%
Urinary Tract Infection: 11 people, 14.10%
Itching: 10 people, 12.82%
Reflux Laryngitis (voice disorder caused by backflow of stomach fluids to the throat and voice box area): 10 people, 12.82%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 9 people, 11.54%

* Approximation only. Some reports may have incomplete information.

Do you take Methotrexate and have Genital ulceration?

- Check whether Genital ulceration 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 Methotrexate:

Methotrexate (604,313 reports)

Browse all side effects of Methotrexate:

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 Genital ulceration:

Genital ulceration (94 drugs)

Browse all the conditions that are associated with Genital ulceration:

Genital ulceration (198 conditions)

Related publications that referenced our studies

Henien M, Carey B, Hullah E, Sproat C, Patel V, "methotrexate-associated osteonecrosis of the jaw: A report of two cases", Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 2017 Dec .
Henien M, Carey B, Hullah E, Sproat C, Patel V, "methotrexate-associated osteonecrosis of the jaw: A report of two cases", Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology, 2017 Dec .

How the study uses the data?

The study uses data from the FDA. It is based on methotrexate sodium (the active ingredients of Methotrexate) and Methotrexate (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.