Singulair and Lichen sclerosus - a phase IV clinical study of FDA data


Lichen sclerosus is found among people who take Singulair, especially for people who are female, 60+ old.

The phase IV clinical study analyzes which people take Singulair and have Lichen sclerosus. It is created by eHealthMe based on reports of 119,938 people who have side effects when taking Singulair 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, 06, 2023

119,938 people reported to have side effects when taking Singulair.
Among them, 6 people (0.01%) have Lichen sclerosus.

What is Singulair?

Singulair has active ingredients of montelukast sodium. It is often used in asthma. eHealthMe is studying from 115,484 Singulair users for its effectiveness, alternative drugs and more.

What is Lichen sclerosus?

Lichen sclerosus (a skin disorder that causes the skin to become thin, whitened, wrinkled, and can cause itching and pain) is found to be associated with 468 drugs and 236 conditions by eHealthMe.

Number of Singulair and Lichen sclerosus reports submitted per year:

Could Singulair cause Lichen sclerosus?

Gender of people who have Lichen sclerosus when taking Singulair *:

  • female: 100 %
  • male: 0.0 %

Age of people who have Lichen sclerosus when taking Singulair *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 0.0 %
  • 40-49: 0.0 %
  • 50-59: 0.0 %
  • 60+: 100 %

Common drugs people take besides Singulair *:

  1. Topamax: 3 people, 50.00%
  2. Zoloft: 3 people, 50.00%
  3. Ventolin: 3 people, 50.00%
  4. Vitamin D3: 2 people, 33.33%
  5. Ceftin: 1 person, 16.67%
  6. Mesalamine: 1 person, 16.67%
  7. Lyrica: 1 person, 16.67%
  8. Hizentra: 1 person, 16.67%
  9. Dupixent: 1 person, 16.67%
  10. Colchicine: 1 person, 16.67%

Common side effects people have besides Lichen sclerosus *:

  1. Wound: 3 people, 50.00%
  2. Urinary Incontinence (inability to control the flow of urine and involuntary urination): 3 people, 50.00%
  3. Canker Sores (painful, open sore in the mouth): 3 people, 50.00%
  4. Fungal Infection: 3 people, 50.00%
  5. Vulvovaginal Pruritus (vulvovaginal severe itching): 3 people, 50.00%
  6. Psoriatic Arthropathy (inflammation of the skin and joints with kin condition which typically causes patches (plaques) of red, scaly skin to develop): 3 people, 50.00%
  7. Therapeutic Response Unexpected: 3 people, 50.00%
  8. Burning Sensation: 3 people, 50.00%
  9. Urinary Tract Infection: 3 people, 50.00%
  10. Urination - Painful: 3 people, 50.00%

Common conditions people have *:

  1. Relapsing-Remitting Multiple Sclerosis (reoccurrence of an inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged): 3 people, 50.00%
  2. Nasal Polyps (masses that develop in the lining of the nose): 1 person, 16.67%
  3. Depression: 1 person, 16.67%

* Approximation only. Some reports may have incomplete information.

Do you take Singulair and have Lichen sclerosus?

Check whether Lichen sclerosus 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 publications that referenced our studies

Related studies

How severe was Lichen sclerosus and when was it recovered:

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

Alternative drugs to, pros and cons of Singulair:

Common Singulair side effects:

Browse all side effects of Singulair:

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Lichen sclerosus treatments and more:

COVID vaccines that are related to Lichen sclerosus:

All the drugs that are associated with Lichen sclerosus:

All the conditions that are associated with Lichen sclerosus:

How the study uses the data?

The study uses data from the FDA. It is based on montelukast sodium (the active ingredients of Singulair) and Singulair (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 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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