Methotrexate and Type iv hypersensitivity reaction - a phase IV clinical study of FDA data

Summary:

Type iv hypersensitivity reaction is reported as a side effect among people who take Methotrexate (methotrexate sodium), especially for people who are female, 30-39 old, have been taking the drug for 2 - 5 years also take Remicade, and have Crohn's disease.

The phase IV clinical study analyzes which people have Type iv hypersensitivity reaction 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 604,314 Methotrexate users. Check the latest studies of Methotrexate.

What is Type iv hypersensitivity reaction?

Type iv hypersensitivity reaction (delayed type hypersensitivity as the reaction takes two to three days to develop) is found to be associated with 193 drugs and 415 conditions by eHealthMe. Check the latest studies of Type iv hypersensitivity reaction.

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, 30, 2026

599,650 people reported to have side effects when taking Methotrexate.
Among them, 82 people (0.01%) have Type iv hypersensitivity reaction.

Could Methotrexate cause Type iv hypersensitivity reaction?

Among these 82 people:

How long have people been on Methotrexate when they have Type iv hypersensitivity reaction? *

  • < 1 month: 25 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 25 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 50 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Type iv hypersensitivity reaction when taking Methotrexate? *

  • female: 77.03 %
  • male: 22.97 %

What is the age of people who have Type iv hypersensitivity reaction when taking Methotrexate? *

  • 0-1: 0.0 %
  • 2-9: 1.96 %
  • 10-19: 13.73 %
  • 20-29: 1.96 %
  • 30-39: 31.37 %
  • 40-49: 17.65 %
  • 50-59: 7.84 %
  • 60+: 25.49 %

What are other drugs people take besides Methotrexate? *

  1. Remicade: 30 people, 36.59%
  2. Humira: 20 people, 24.39%
  3. Cosentyx: 18 people, 21.95%
  4. Arava: 14 people, 17.07%
  5. Cimzia: 11 people, 13.41%
  6. Leflunomide: 10 people, 12.20%
  7. Folic Acid: 10 people, 12.20%
  8. Tylenol: 10 people, 12.20%
  9. Actemra: 10 people, 12.20%
  10. Simponi: 9 people, 10.98%

What are other side effects people have besides Type iv hypersensitivity reaction? *

  1. Drug Ineffective: 32 people, 39.02%
  2. Joint Pain: 26 people, 31.71%
  3. Diarrhea: 23 people, 28.05%
  4. Gastrointestinal Disorder (functional problems of gastrointestinal tract): 20 people, 24.39%
  5. Drug Intolerance (drug sensitivity): 19 people, 23.17%
  6. Nausea (feeling of having an urge to vomit): 14 people, 17.07%
  7. Hypersensitivity: 14 people, 17.07%
  8. Eczema (patches of skin become rough and inflamed, with itching and bleeding blisters): 14 people, 17.07%
  9. Abdominal Pain: 13 people, 15.85%
  10. Joint Injury: 12 people, 14.63%

What are the existing conditions these people have? *

  1. Crohn's Disease (a condition that causes inflammation of the gastrointestinal tract): 25 people, 30.49%
  2. Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 14 people, 17.07%
  3. Psoriasis (immune-mediated disease that affects the skin): 13 people, 15.85%
  4. Ankylosing Spondylitis (type of arthritis affecting the spine): 11 people, 13.41%
  5. Osteopenia (a condition where bone mineral density is lower than normal): 3 people, 3.66%
  6. Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 2 people, 2.44%
  7. B-Cell Type Acute Leukaemia (cancer of the white blood cells): 2 people, 2.44%
  8. Pain: 2 people, 2.44%
  9. Non-Hodgkin's Lymphoma (malignant (cancer) cells form in the lymph system): 2 people, 2.44%
  10. Colitis (inflammation of colon): 2 people, 2.44%

* Approximation only. Some reports may have incomplete information.

Do you take Methotrexate and have Type iv hypersensitivity reaction?

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Related studies:

Effectiveness of, long term effects of, and alternative drugs to Methotrexate:

Type iv hypersensitivity reaction treatments and more:

How severe was Type iv hypersensitivity reaction and when was it recovered:

Expand to all the drugs that have ingredients of methotrexate sodium:

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 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 Type iv hypersensitivity reaction:

Browse all the conditions that are associated with Type iv hypersensitivity reaction:

Related publications that referenced our studies


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.



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