Methotrexate and Infusion site oedema - a phase IV clinical study of FDA data

Summary:

Infusion site oedema is reported as a side effect among people who take Methotrexate (methotrexate sodium), especially for people who are female, 40-49 old, have been taking the drug for 6 - 12 months also take Inflectra, and have Abscess.

The phase IV clinical study analyzes which people have Infusion site oedema 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 604,312 Methotrexate users. Check the latest studies of Methotrexate.

What is Infusion site oedema?

Infusion site oedema (swelling from excessive accumulation of watery fluid from infusion site) is found to be associated with 142 drugs and 102 conditions by eHealthMe. Check the latest studies of Infusion site oedema.



On Jul, 11, 2026

599,650 people reported to have side effects when taking Methotrexate.
Among them, 46 people (0.01%) have Infusion site oedema.

Could Methotrexate cause Infusion site oedema?

Among these 46 people:

How long have people been on Methotrexate when they have Infusion site oedema? *

  • < 1 month: 11.11 %
  • 1 - 6 months: 22.22 %
  • 6 - 12 months: 33.33 %
  • 1 - 2 years: 33.33 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Infusion site oedema when taking Methotrexate? *

  • female: 93.33 %
  • male: 6.67 %

What is the age of people who have Infusion site oedema when taking Methotrexate? *

  • 0-1: 10.71 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 7.14 %
  • 40-49: 67.86 %
  • 50-59: 7.14 %
  • 60+: 7.14 %

What are other drugs people take besides Methotrexate? *

  1. Inflectra: 16 people, 34.78%
  2. Synthroid: 15 people, 32.61%
  3. Lyrica: 15 people, 32.61%
  4. Fragmin: 13 people, 28.26%
  5. Dilaudid: 13 people, 28.26%
  6. Ancef: 13 people, 28.26%
  7. Cardizem: 13 people, 28.26%
  8. Actonel: 13 people, 28.26%
  9. Venofer: 13 people, 28.26%
  10. Tylenol: 12 people, 26.09%

What are other side effects people have besides Infusion site oedema? *

  1. Infusion Site Pain: 26 people, 56.52%
  2. Pain: 22 people, 47.83%
  3. Secretion Discharge: 20 people, 43.48%
  4. Infusion Site Erythema (reddening of the skin at infusion site): 19 people, 41.30%
  5. Headache (pain in head): 19 people, 41.30%
  6. Fatigue (feeling of tiredness): 18 people, 39.13%
  7. Sinusitis (inflammation of sinus): 17 people, 36.96%
  8. High Blood Pressure: 16 people, 34.78%
  9. Systemic Lupus Erythematosus (an autoimmune disease, which means the body's immune system mistakenly, attacks healthy tissue): 13 people, 28.26%
  10. Infusion Site Warmth: 13 people, 28.26%

What are the existing conditions these people have? *

  1. Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 12 people, 26.09%
  2. Abscess (pus): 12 people, 26.09%
  3. Pain: 11 people, 23.91%
  4. Deep Venous Thrombosis (blood clot in a major vein that usually develops in the legs and/or pelvis): 10 people, 21.74%
  5. Thrombophlebitis (swelling (inflammation) of a vein caused by a blood clot): 9 people, 19.57%
  6. Systemic Lupus Erythematosus (an autoimmune disease, which means the body's immune system mistakenly, attacks healthy tissue): 7 people, 15.22%
  7. Crohn's Disease (a condition that causes inflammation of the gastrointestinal tract): 5 people, 10.87%
  8. Anorectal Discomfort: 5 people, 10.87%
  9. Wound Infection: 3 people, 6.52%
  10. Psoriasis (immune-mediated disease that affects the skin): 3 people, 6.52%

* Approximation only. Some reports may have incomplete information.

Do you take Methotrexate and have Infusion site oedema?

- Check whether Infusion site oedema is associated with a drug or a condition
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Related studies:

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

Infusion site oedema treatments and more:

How severe was Infusion site oedema 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 Infusion site oedema:

Browse all the conditions that are associated with Infusion site oedema:

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.

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