Montelukast
According to the FDA label: 1. INDICATIONS AND USAGE Montelukast sodium tablets are a leukotriene receptor antagonist indicated for: • Prophylaxis and chronic treatment of asthma in patients 2 years of age and older ( 1.1 ). • Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ).
55,466 adverse event reports submitted to the FDA (2002–2026)
Top Reported Adverse Events
The most frequently reported events in association with Montelukast in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Dyspnoea 5,293 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Asthma 4,840 reports
A condition where the airways narrow and swell, causing wheezing and difficulty breathing.
Full definition in the glossary →Drug Ineffective 4,254 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Fatigue 3,749 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Cough 3,024 reports
A reflex that clears the throat or airways.
Full definition in the glossary → See all drugs reporting this event →Headache 2,953 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 2,888 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Nausea 2,887 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 2,713 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Anxiety 2,415 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 2,379 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Pain 2,365 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Wheezing 2,038 reports
A whistling sound when breathing, usually a sign the airways are narrowed.
Full definition in the glossary →Pruritus 2,010 reports
Malaise 2,004 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 33,737 |
| Male | 16,623 |
| Unknown | 39 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 4,286 |
| 18-34 | 3,608 |
| 35-49 | 5,678 |
| 50-64 | 10,980 |
| 65-74 | 8,176 |
| 75+ | 5,758 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Montelukast. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 26,134 |
| Non-Serious | 18,138 |
| Hospitalization | 15,699 |
| Death | 2,694 |
| Life-Threatening | 2,172 |
| Disability | 2,156 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Montelukast. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2002 | 1 |
| 2004 | 51 |
| 2005 | 64 |
| 2006 | 71 |
| 2007 | 8 |
| 2008 | 3 |
| 2009 | 175 |
| 2010 | 265 |
| 2011 | 110 |
| 2012 | 418 |
| 2013 | 799 |
| 2014 | 1,127 |
| 2015 | 1,982 |
| 2016 | 2,669 |
| 2017 | 3,154 |
| 2018 | 4,383 |
| 2019 | 6,167 |
| 2020 | 6,338 |
| 2021 | 5,596 |
| 2022 | 4,698 |
| 2023 | 5,158 |
| 2024 | 5,873 |
| 2025 | 5,068 |
| 2026 (partial) | 1,288 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Montelukast
In FDA adverse event reports that mention Montelukast, these medications appeared most often in the same report.
- Albuterol (14,017 reports)
- Prednisone (8,507 reports)
- Omeprazole (8,389 reports)
- Ergocalciferol (7,005 reports)
- Cetirizine (6,639 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026