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

Summary:

Fibrosis is reported as a side effect among people who take Singulair (montelukast sodium), especially for people who are male, 60+ old, have been taking the drug for < 1 month also take Spiriva, and have Nasal congestion.

The phase IV clinical study analyzes which people have Fibrosis 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 Fibrosis?

Fibrosis (formation of excess fibrous connective tissue in an organ or tissue) is found to be associated with 697 drugs and 681 conditions by eHealthMe. Check the latest studies of Fibrosis.

On Jul, 27, 2026

125,532 people reported to have side effects when taking Singulair.
Among them, 44 people (0.04%) have Fibrosis.

Among these 44 people:

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

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

female: 40.48 %
male: 59.52 %

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

What are other drugs people take besides Singulair? *

What are other side effects people have besides Fibrosis? *

Fatigue (feeling of tiredness): 21 people, 47.73%
Cough: 19 people, 43.18%
Pneumonia: 15 people, 34.09%
Pain: 12 people, 27.27%
Dyspnea Exertional: 12 people, 27.27%
Weakness: 11 people, 25.00%
Nephrogenic Systemic Fibrosis (involves fibrosis of skin, joints, eyes due to kidney disease): 10 people, 22.73%
Dyspnea (difficult or laboured breathing): 10 people, 22.73%
Wheezing (a high-pitched whistling sound made while you breath): 9 people, 20.45%
Pain In Extremity: 9 people, 20.45%

What are the existing conditions these people have? *

Idiopathic Pulmonary Fibrosis (chronic lung disease): 6 people, 13.64%
Nasal Congestion (blockage of the nasal passages usually due to membranes lining the nose becoming swollen from inflamed blood vessels): 6 people, 13.64%
Hypothyroidism (abnormally low activity of the thyroid gland, resulting in retardation of growth and mental development): 4 people, 9.09%
Gout (uric acid crystals building up in the body): 4 people, 9.09%
Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 3 people, 6.82%
Eczema (patches of skin become rough and inflamed, with itching and bleeding blisters): 2 people, 4.55%
Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 2 people, 4.55%
Immunodeficiency Common Variable: 2 people, 4.55%
Restless Leg Syndrome (a powerful urge to move your legs): 2 people, 4.55%
Hypersensitivity: 1 person, 2.27%

* Approximation only. Some reports may have incomplete information.

Do you take Singulair and have Fibrosis?

- Check whether Fibrosis 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:

Singulair (129,752 reports)

Fibrosis treatments and more:

Fibrosis (4,958 reports)

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 Fibrosis:

Fibrosis (697 drugs)

Browse all the conditions that are associated with Fibrosis:

Fibrosis (681 conditions)

Related publications that referenced our studies

Das S, Mondal S, Dey JK, Bandyopadhyay S, Saha I, Tripathi SK, "A case of montelukast induced hypercholesterolemia, severe hypertriglyceridemia and pancreatitis", Journal of Young Pharmacists, 2013 Jun .
Das S, Mondal S, Dey JK, Bandyopadhyay S, Saha I, Tripathi SK, "A case of montelukast induced hypercholesterolemia, severe hypertriglyceridemia and pancreatitis", Journal of Young Pharmacists, 2013 Jun .

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.