Singulair and Polycythaemia - a phase IV clinical study of FDA data

Summary:

Polycythaemia is reported as a side effect among people who take Singulair (montelukast sodium), especially for people who are female, 30-39 old, have been taking the drug for 5 - 10 years also take Xyrem, and have Insomnia.

The phase IV clinical study analyzes which people have Polycythaemia when taking Singulair. It is created by eHealthMe based on reports of 125,532 people who have side effects when taking Singulair from the FDA, and is updated regularly.

What is Singulair?

Singulair has active ingredients of montelukast sodium. It is often used in asthma. eHealthMe is studying from 129,752 Singulair users. Check the latest studies of Singulair.

What is Polycythaemia?

Polycythaemia (proportion of blood volume that is occupied by red blood cells increases) is found to be associated with 278 drugs and 448 conditions by eHealthMe. Check the latest studies of Polycythaemia.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.



On Sep, 02, 2026

125,532 people reported to have side effects when taking Singulair.
Among them, 20 people (0.02%) have Polycythaemia.

Could Singulair cause Polycythaemia?

Among these 20 people:

How long have people been on Singulair when they have Polycythaemia? *

  • < 1 month: 0.0 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 14.29 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 28.57 %
  • 5 - 10 years: 57.14 %
  • 10+ years: 0.0 %

What is the gender of people who have Polycythaemia when taking Singulair? *

  • female: 78.95 %
  • male: 21.05 %

What is the age of people who have Polycythaemia when taking Singulair? *

  • 0-1: 0.0 %
  • 2-9: 11.11 %
  • 10-19: 0.0 %
  • 20-29: 0.0 %
  • 30-39: 33.33 %
  • 40-49: 22.22 %
  • 50-59: 11.11 %
  • 60+: 22.22 %

What are other drugs people take besides Singulair? *

  1. Xyrem: 7 people, 35.00%
  2. Cymbalta: 6 people, 30.00%
  3. Zyrtec: 5 people, 25.00%
  4. Colace: 5 people, 25.00%
  5. Mucinex: 5 people, 25.00%
  6. Xanax: 5 people, 25.00%
  7. Spiriva Respimat: 5 people, 25.00%
  8. Melatonin: 4 people, 20.00%
  9. Lunesta: 4 people, 20.00%
  10. Nuvigil: 4 people, 20.00%

What are other side effects people have besides Polycythaemia? *

  1. Wheezing (a high-pitched whistling sound made while you breath): 9 people, 45.00%
  2. Dyspnea (difficult or laboured breathing): 9 people, 45.00%
  3. Sleep Disorder: 7 people, 35.00%
  4. Drug Intolerance (drug sensitivity): 6 people, 30.00%
  5. Blood Count Abnormal: 5 people, 25.00%
  6. Generalized Anxiety Disorder (excessive, uncontrollable, unexplained and often irrational worry): 4 people, 20.00%
  7. Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 4 people, 20.00%
  8. Memory Loss: 4 people, 20.00%
  9. Rashes (redness): 4 people, 20.00%
  10. Insomnia (sleeplessness): 4 people, 20.00%

What are the existing conditions these people have? *

  1. Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 4 people, 20.00%
  2. Insomnia (sleeplessness): 4 people, 20.00%
  3. Urticaria Pigmentosa (skin disease that produces patches of darker skin (lesions) and very bad itching): 2 people, 10.00%
  4. Suicidal Ideation: 2 people, 10.00%
  5. Peripheral Coldness: 2 people, 10.00%
  6. Multiple Myeloma (cancer of the plasma cells): 2 people, 10.00%
  7. Hypersensitivity: 2 people, 10.00%
  8. Drowsiness: 2 people, 10.00%
  9. Chronic Obstructive Pulmonary Disease (a progressive disease that makes it hard to breathe): 2 people, 10.00%
  10. Cataplexy (loss of muscle tone accompanied by full conscious awareness): 2 people, 10.00%

* Approximation only. Some reports may have incomplete information.

Do you take Singulair and have Polycythaemia?

- Check whether Polycythaemia is associated with a drug or a condition
- Predict drug outcomes for up to one year with AI
- Get an AI agent to monitor your drugs continuously



Related studies:

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

Polycythaemia treatments and more:

How severe was Polycythaemia and when was it recovered:

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

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 Polycythaemia:

Browse all the conditions that are associated with Polycythaemia:

Related publications that referenced our studies


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.

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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