Tacrolimus and Proctitis - a phase IV clinical study of FDA data

Summary:

Proctitis is reported as a side effect among people who take Tacrolimus (tacrolimus), especially for people who are male, 60+ old, have been taking the drug for 1 - 6 months also take Prednisone, and have Crohn's disease.

The phase IV clinical study analyzes which people have Proctitis when taking Tacrolimus. It is created by eHealthMe based on reports of 115,828 people who have side effects when taking Tacrolimus from the FDA, and is updated regularly.

What is Tacrolimus?

Tacrolimus has active ingredients of tacrolimus. It is often used in kidney transplant. eHealthMe is studying from 116,160 Tacrolimus users. Check the latest studies of Tacrolimus.

What is Proctitis?

Proctitis (inflammation of the rectum and anus) is found to be associated with 467 drugs and 616 conditions by eHealthMe. Check the latest studies of Proctitis.



On Jul, 15, 2026

115,828 people reported to have side effects when taking Tacrolimus.
Among them, 37 people (0.03%) have Proctitis.

Could Tacrolimus cause Proctitis?

Among these 37 people:

How long have people been on Tacrolimus when they have Proctitis? *

  • < 1 month: 0.0 %
  • 1 - 6 months: 100 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Proctitis when taking Tacrolimus? *

  • female: 39.39 %
  • male: 60.61 %

What is the age of people who have Proctitis when taking Tacrolimus? *

  • 0-1: 0.0 %
  • 2-9: 4.17 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 25.0 %
  • 40-49: 20.83 %
  • 50-59: 16.67 %
  • 60+: 33.33 %

What are other drugs people take besides Tacrolimus? *

  1. Prednisone: 7 people, 18.92%
  2. Humira: 6 people, 16.22%
  3. Mycophenolate Mofetil: 6 people, 16.22%
  4. Stelara: 4 people, 10.81%
  5. Methylprednisolone: 4 people, 10.81%
  6. Linezolid: 4 people, 10.81%
  7. Entyvio: 3 people, 8.11%
  8. Ondansetron: 2 people, 5.41%
  9. Methotrexate: 2 people, 5.41%
  10. Vancomycin: 2 people, 5.41%

What are other side effects people have besides Proctitis? *

  1. Escherichia Sepsis (bacterial infection by escherichia coli): 11 people, 29.73%
  2. Cytomegalovirus Infection: 9 people, 24.32%
  3. Sepsis (a severe blood infection that can lead to organ failure and death): 7 people, 18.92%
  4. Escherichia Infection (bacterial infection by escherichia coli): 7 people, 18.92%
  5. Diarrhea: 7 people, 18.92%
  6. Pyoderma Gangrenosum (ulcerating condition of skin that results in heaped borders with a typical appearance): 6 people, 16.22%
  7. Disease Recurrence: 6 people, 16.22%
  8. Inflammation: 6 people, 16.22%
  9. Pulmonary Cavitation (cavity in the lung): 6 people, 16.22%
  10. Bacteraemia (presence of bacteria in the blood): 6 people, 16.22%

What are the existing conditions these people have? *

  1. Crohn's Disease (a condition that causes inflammation of the gastrointestinal tract): 10 people, 27.03%
  2. Transplant Rejection (a transplant material is not worked): 4 people, 10.81%
  3. Nocardia Infection (a bacterial infection that usually starts in the lungs. it may spread to other organ systems): 4 people, 10.81%
  4. Immunodeficiency Disorders: 4 people, 10.81%
  5. Immunodeficiency Common Variable: 4 people, 10.81%
  6. Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 3 people, 8.11%
  7. Proctitis Fungal (inflammation of the rectum and anus by fungal infection): 2 people, 5.41%
  8. Nausea And Vomiting: 2 people, 5.41%
  9. Nausea (feeling of having an urge to vomit): 2 people, 5.41%
  10. Dry Skin: 2 people, 5.41%

* Approximation only. Some reports may have incomplete information.

Do you take Tacrolimus and have Proctitis?

- Check whether Proctitis is associated with a drug or a condition
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Related studies:

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

Proctitis treatments and more:

How severe was Proctitis and when was it recovered:

Expand to all the drugs that have ingredients of tacrolimus:

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 Tacrolimus:

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 Proctitis:

Browse all the conditions that are associated with Proctitis:


How the study uses the data?

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