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


Cheilitis is found among people who take Tacrolimus, especially for people who are female, 40-49 old, have been taking the drug for < 1 month.

The phase IV clinical study analyzes which people take Tacrolimus and have Cheilitis. It is created by eHealthMe based on reports of 90,919 people who have side effects when taking Tacrolimus from the FDA, and is updated regularly. You can use the study as a second opinion to make health care decisions.

Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. Our original studies have been referenced on 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Sep, 20, 2022

90,919 people reported to have side effects when taking Tacrolimus.
Among them, 25 people (0.03%) have Cheilitis.

What is Tacrolimus?

Tacrolimus has active ingredients of tacrolimus. It is often used in kidney transplant. eHealthMe is studying from 91,214 Tacrolimus users for its effectiveness, alternative drugs and more.

What is Cheilitis?

Cheilitis (infection of lips) is found to be associated with 1,283 drugs and 854 conditions by eHealthMe.

Number of Tacrolimus and Cheilitis reports submitted per year:

Could Tacrolimus cause Cheilitis?

Time on Tacrolimus when people have Cheilitis *:

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

Gender of people who have Cheilitis when taking Tacrolimus *:

  • female: 68.18 %
  • male: 31.82 %

Age of people who have Cheilitis when taking Tacrolimus *:

  • 0-1: 0.0 %
  • 2-9: 9.09 %
  • 10-19: 4.55 %
  • 20-29: 9.09 %
  • 30-39: 0.0 %
  • 40-49: 45.45 %
  • 50-59: 18.18 %
  • 60+: 13.64 %

Common drugs people take besides Tacrolimus *:

  1. Prednisolone: 5 people, 20.00%
  2. Imuran: 5 people, 20.00%
  3. Acitretin: 3 people, 12.00%
  4. Atarax: 3 people, 12.00%
  5. Lipitor: 3 people, 12.00%
  6. Omeprazole: 3 people, 12.00%
  7. Mestinon: 3 people, 12.00%
  8. Urso 250: 3 people, 12.00%
  9. Vitamin D3: 3 people, 12.00%
  10. Bactrim: 2 people, 8.00%

Common side effects people have besides Cheilitis *:

  1. Stomatitis (inflammation of mucous membrane of mouth): 9 people, 36.00%
  2. Itching: 5 people, 20.00%
  3. Enterocolitis (inflammation of the digestive tract, involving enteritis of the small intestine and colitis of the colon): 5 people, 20.00%
  4. Glossitis (infection of tongue with soreness): 5 people, 20.00%
  5. Insomnia (sleeplessness): 4 people, 16.00%
  6. Headache (pain in head): 4 people, 16.00%
  7. Xerosis (abnormal dryness of the skin or mucus membranes): 3 people, 12.00%
  8. Hyperglycemia (high blood sugar): 3 people, 12.00%
  9. Malaise (a feeling of general discomfort or uneasiness): 3 people, 12.00%
  10. Jaundice - Yellow Skin (a yellowish pigmentation of the skin): 3 people, 12.00%

Common conditions people have *:

  1. Musculoskeletal Stiffness (stiffness of the body's muscles, joints, tendons, ligaments and nerves): 3 people, 12.00%
  2. Graft Versus Host Disease (the donated bone marrow or stem cells view the recipient's body as foreign, and the donated cells/bone marrow attack the body): 3 people, 12.00%
  3. Skin Papilloma (a general medical term for a tumour of the skin or mucous membrane with finger-like projections): 3 people, 12.00%
  4. Headache (pain in head): 3 people, 12.00%
  5. Arthritis (form of joint disorder that involves inflammation of one or more joints): 3 people, 12.00%
  6. Asthma: 3 people, 12.00%
  7. Insomnia (sleeplessness): 3 people, 12.00%
  8. Myasthenia Gravis (a chronic condition that causes muscles to tire and weaken easily): 3 people, 12.00%
  9. Stomatitis (inflammation of mucous membrane of mouth): 3 people, 12.00%
  10. Lupus Nephritis (a chronic inflammatory autoimmune disorder that may affect kidney tissue): 3 people, 12.00%

* Approximation only. Some reports may have incomplete information.

Do you take Tacrolimus and have Cheilitis?

Check whether Cheilitis is associated with a drug or a condition

How to use the study?

You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood.

Related studies

How severe was Cheilitis and when was it recovered:

Expand to all the drugs that have ingredients of tacrolimus:

Alternative drugs to, pros and cons of Tacrolimus:

Common Tacrolimus side effects:

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

Cheilitis treatments and more:

COVID vaccines that are related to Cheilitis:

Common drugs associated with Cheilitis:

All the drugs that are associated with Cheilitis:

Common conditions associated with Cheilitis:

All the conditions that are associated with Cheilitis:

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.

Who is eHealthMe?

With medical big data and proven AI 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 600+ 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: 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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