Protopic and Otitis externa - a phase IV clinical study of FDA data

Summary:

Otitis externa is reported as a side effect among people who take Protopic (tacrolimus), especially for people who are female, 60+ old, also take Cosentyx, and have Dermatitis atopic.

The phase IV clinical study analyzes which people have Otitis externa when taking Protopic. It is created by eHealthMe based on reports of 5,328 people who have side effects when taking Protopic from the FDA, and is updated regularly.

What is Protopic?

Protopic has active ingredients of tacrolimus. It is often used in eczema. eHealthMe is studying from 5,403 Protopic users. Check the latest studies of Protopic.

What is Otitis externa?

Otitis externa (external ear infection) is found to be associated with 492 drugs and 409 conditions by eHealthMe. Check the latest studies of Otitis externa.



On Jan, 03, 2026

5,328 people reported to have side effects when taking Protopic.
Among them, 8 people (0.15%) have Otitis externa.

Could Protopic cause Otitis externa?

Among these 8 people:

What is the gender of people who have Otitis externa when taking Protopic? *

  • female: 87.5 %
  • male: 12.5 %

What is the age of people who have Otitis externa when taking Protopic? *

  • 0-1: 0.0 %
  • 2-9: 14.29 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 0.0 %
  • 50-59: 42.86 %
  • 60+: 42.86 %

What are other drugs people take besides Protopic? *

  1. Cosentyx: 6 people, 75.00%
  2. Taltz: 2 people, 25.00%
  3. Loprox: 2 people, 25.00%
  4. Lidex: 2 people, 25.00%
  5. Elidel: 2 people, 25.00%
  6. Dovonex: 2 people, 25.00%
  7. Derma-Smoothe/fs: 2 people, 25.00%
  8. Cutivate: 2 people, 25.00%
  9. Bactroban: 2 people, 25.00%
  10. Allegra: 2 people, 25.00%

What are other side effects people have besides Otitis externa? *

  1. Otitis (ear infection): 6 people, 75.00%
  2. Cellulitis (infection under the skin): 6 people, 75.00%
  3. Synovial Cyst (cyst of joint filled with synovial fluid): 4 people, 50.00%
  4. Asthma: 4 people, 50.00%
  5. Osteoarthritis (a joint disease caused by cartilage loss in a joint): 4 people, 50.00%
  6. Bronchitis (inflammation of the mucous membrane in the bronchial tubes): 4 people, 50.00%
  7. Bronchitis Bacterial (inflammation of the mucous membrane in the bronchial tubes due to bacterial infection): 4 people, 50.00%
  8. Sinusitis (inflammation of sinus): 4 people, 50.00%
  9. Foot Deformity (functional disability of foot): 2 people, 25.00%
  10. Eye Pruritus (eye itching): 2 people, 25.00%

What are the existing conditions these people have? *

  1. Dermatitis Atopic (inflammatory, chronically relapsing, non-contagious and pruritic skin disorder): 2 people, 25.00%
  2. Type 2 Diabetes: 1 person, 12.50%
  3. Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 1 person, 12.50%
  4. Diabetes: 1 person, 12.50%

* Approximation only. Some reports may have incomplete information.

Do you take Protopic and have Otitis externa?

- Check whether Otitis externa is associated with a drug or a condition (FREE)
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Related studies:

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

Otitis externa treatments and more:

How severe was Otitis externa 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 Protopic:

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 Otitis externa:

Browse all the conditions that are associated with Otitis externa:


How the study uses the data?

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