Montelukast adverse event reports that FDA received
- Name type
- Generic name
- Class
- Leukotriene receptor antagonist
- Also reported as
- Montelukast 4mg, Montelukast /01362602/, Montelukast 10mg Tablets
What a report is
A report is not proof that the drug was the cause of the event.
FDA says:
Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .
FDA also says:
There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .
Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.
Drug reports received through . Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.
Reports on file
From January 2004 to June 2026, FDA received 12,863 adverse event reports that name Montelukast. In these reports the drug is a suspect or interacting product.
In the same period, 44,459 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.
FDA received 1,066 reports in the 12 months to June 2026 and 1,238 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.
Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 1,066 (0.1%) name Montelukast. Reports for patients aged 2 to 11 were 15.6% of the reports that name Montelukast and 1.4% of all drug reports.
The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.
There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
Suspect product
FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Montelukast is suspect or interacting. FDA says:
Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
Data version
openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.
Since the last update
FDA says:
Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
The latest update of the FDA data, recorded on , changed no count of this page.
- In April to June 2026, FDA received 177 reports that name Montelukast.
- In January to March 2026, FDA received 341.
- In April to June 2025, FDA received 169.
April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.
Reaction lookup
These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.
What this list leaves out
The table lists the 1,231 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.
The site keeps reaction terms for 12,814 of the 12,863 reports (99.6%).
The reports of the other years are not in the counts.
So a count in the table can be lower than the count of FDA.
The table shows the first 50 of 1,231 terms.
| Reaction term (MedDRA) and plain meaning | Reports | Share of the 12,863 reports |
|---|---|---|
| Asthma | 2,362 | 18.4% |
| Dyspnoeashortness of breath | 1,898 | 14.8% |
| Drug ineffectivethe medicine did not work as expected | 1,726 | 13.4% |
| Anxiety | 1,535 | 11.9% |
| Wheezing | 1,272 | 9.9% |
| Cough | 1,119 | 8.7% |
| Depressionlow mood | 880 | 6.8% |
| Headachehead pain | 808 | 6.3% |
| Fatiguetiredness | 806 | 6.3% |
| Nightmarenightmares | 784 | 6.1% |
| Aggressionaggressive behaviour | 776 | 6% |
| Insomniadifficulty sleeping | 776 | 6% |
| Pneumonialung infection | 741 | 5.8% |
| Therapeutic product effect incomplete | 705 | 5.5% |
| Urticariahives | 687 | 5.3% |
| Off label useused for a purpose or in a way not on the label | 680 | 5.3% |
| Malaisegeneral feeling of being unwell | 643 | 5% |
| Suicidal ideationthoughts of suicide | 625 | 4.9% |
| Painpain, site not specified | 564 | 4.4% |
| Obstructive airways disorder | 562 | 4.4% |
| Vomitingbeing sick | 560 | 4.4% |
| Drug hypersensitivityan allergic-type reaction (the term names a medicine) | 535 | 4.2% |
| Chest discomfort | 507 | 3.9% |
| Loss of personal independence in daily activities | 500 | 3.9% |
| Condition aggravatedthe condition being treated got worse | 499 | 3.9% |
| Nauseafeeling sick | 496 | 3.9% |
| Pruritusitching | 491 | 3.8% |
| Anger | 486 | 3.8% |
| Pyrexiafever | 478 | 3.7% |
| Sleep disordera sleep problem | 467 | 3.6% |
| Dizzinesslight-headedness or unsteadiness | 463 | 3.6% |
| Depressed moodlow mood | 450 | 3.5% |
| Abnormal behaviourunusual behaviour | 403 | 3.1% |
| Gastrooesophageal reflux diseaseacid reflux | 403 | 3.1% |
| Sleep terror | 399 | 3.1% |
| Hypertensionhigh blood pressure | 389 | 3% |
| Sleep disorder due to a general medical condition | 385 | 3% |
| Rashskin rash | 362 | 2.8% |
| Productive cougha cough with phlegm | 342 | 2.7% |
| Hypersensitivityan allergic-type reaction | 340 | 2.6% |
| Product use in unapproved indicationused for a purpose not on the label | 330 | 2.6% |
| Lower respiratory tract infectiona chest infection | 319 | 2.5% |
| Weight increasedweight gain | 319 | 2.5% |
| Blood count abnormal | 312 | 2.4% |
| Agitationrestlessness | 309 | 2.4% |
| Full blood count abnormal | 300 | 2.3% |
| Irritability | 297 | 2.3% |
| Hallucinationseeing or hearing things that are not there | 296 | 2.3% |
| Eosinophilic granulomatosis with polyangiitis | 290 | 2.3% |
| Nasopharyngitisa cold | 284 | 2.2% |
The counts add to more than 12,863 reports, because one report can record more than one term. FDA says:
No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
The CSV file has the same rows and the same limits. Its last row is a note that says so.
MedDRA term
The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.
Not the label
The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.
Same ingredient, other names
Reporters write a brand name or a generic name. Each name has its own page and its own count.
| Name | Name type | Reports |
|---|---|---|
| Montelukast (this page) | Generic name | 12,863 |
| Montelukast sodium | Generic name | 6,701 |
| Singulair | Brand name | 18,951 |
Sum of the separately reported names: 38,515. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.
FDA says:
Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
Outcomes by year
The table gives the outcomes that the reporters gave, in the terms of FDA.
Outcomes in the reports that name Montelukast, by the year of the openFDA file that holds the report
The table continues to the right.
| Year of the openFDA file | Reports | Serious | Death | Life-threatening | Hospitalization (initial or prolonged) | Disability or Permanent Damage | Congenital Anomaly/Birth Defect | Other Serious (Important Medical Events) | Not serious |
|---|---|---|---|---|---|---|---|---|---|
| 2004 | 4 | 3 | 0 | 0 | 2 | 0 | 0 | 2 | 1 |
| 2005 | 23 | 23 | 7 | 1 | 12 | 0 | 0 | 5 | 0 |
| 2006 | 8 | 8 | 0 | 0 | 4 | 0 | 0 | 5 | 0 |
| 2007 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| 2008 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| 2009 | 11 | 11 | 2 | 0 | 3 | 0 | 0 | 7 | 0 |
| 2010 | 23 | 21 | 4 | 2 | 5 | 0 | 0 | 14 | 2 |
| 2011 | 20 | 19 | 18 | 0 | 0 | 0 | 0 | 1 | 1 |
| 2012 | 117 | 88 | 22 | 5 | 16 | 3 | 0 | 54 | 29 |
| 2013 | 283 | 237 | 15 | 20 | 42 | 30 | 1 | 159 | 46 |
| 2014 | 250 | 199 | 2 | 20 | 34 | 12 | 10 | 142 | 51 |
| 2015 | 327 | 260 | 12 | 9 | 56 | 20 | 0 | 198 | 67 |
| 2016 | 379 | 293 | 15 | 15 | 84 | 47 | 9 | 187 | 86 |
| 2017 | 465 | 371 | 26 | 30 | 100 | 34 | 2 | 287 | 94 |
| 2018 | 750 | 599 | 27 | 32 | 154 | 68 | 2 | 464 | 151 |
| 2019 | 1,359 | 1,258 | 26 | 60 | 297 | 140 | 10 | 1,037 | 101 |
| 2020 | 1,427 | 1,286 | 54 | 94 | 352 | 139 | 14 | 959 | 141 |
| 2021 | 1,322 | 1,233 | 17 | 99 | 389 | 142 | 11 | 1,026 | 89 |
| 2022 | 1,163 | 1,032 | 32 | 59 | 335 | 51 | 1 | 855 | 131 |
| 2023 | 1,356 | 1,262 | 39 | 116 | 361 | 119 | 9 | 1,060 | 94 |
| 2024 | 1,741 | 1,610 | 57 | 140 | 364 | 193 | 3 | 1,405 | 131 |
| 2025 | 1,153 | 1,080 | 58 | 103 | 353 | 60 | 4 | 974 | 73 |
| 2026 | 680 | 651 | 80 | 68 | 172 | 47 | 19 | 588 | 29 |
An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:
The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:
The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on .
The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.
Reports by year and month
The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.
Show the figures of the chart as a table
| Year | Reports |
|---|---|
| 2004 | 4 |
| 2005 | 22 |
| 2006 | 8 |
| 2007 | 2 |
| 2009 | 11 |
| 2010 | 20 |
| 2011 | 13 |
| 2012 | 133 |
| 2013 | 289 |
| 2014 | 250 |
| 2015 | 344 |
| 2016 | 393 |
| 2017 | 501 |
| 2018 | 825 |
| 2019 | 1,592 |
| 2020 | 1,611 |
| 2021 | 1,372 |
| 2022 | 1,056 |
| 2023 | 1,291 |
| 2024 | 1,624 |
| 2025 | 984 |
| 2026 | 518 |
FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.
Why a count moves
A count moves for many reasons. The guide gives FDA's words about them.
Patients and reporters
| Age | Reports | Share | Share as a bar |
|---|---|---|---|
| Under 2 | 184 | 1.4% | |
| 2 to 11 | 2,005 | 15.6% | |
| 12 to 17 | 540 | 4.2% | |
| 18 to 44 | 2,318 | 18% | |
| 45 to 64 | 2,718 | 21.1% | |
| 65 to 74 | 1,310 | 10.2% | |
| 75 and over | 811 | 6.3% | |
| Age not given | 2,977 | 23.1% |
| Sex | Reports | Share | Share as a bar |
|---|---|---|---|
| Female | 7,314 | 56.9% | |
| Male | 4,264 | 33.1% | |
| Unknown or not given | 1,285 | 10% |
| Reporter | Reports | Share | Share as a bar |
|---|---|---|---|
| Physician | 2,820 | 21.9% | |
| Pharmacist | 734 | 5.7% | |
| Other health professional | 3,796 | 29.5% | |
| Lawyer | 5 | under 0.1% | |
| Consumer or non-health professional | 5,257 | 40.9% | |
| Not given | 251 | 2% |
Age and sex are as the report gives them. The reporter is the primary source in the report. 24.7% of the reports give the United States as the country.
Reason for use
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Asthma | 3,796 | 29.5% |
| Chronic spontaneous urticaria | 301 | 2.3% |
| Hypersensitivity | 283 | 2.2% |
| Ill-defined disorder | 170 | 1.3% |
| Multiple allergies | 163 | 1.3% |
| Adverse drug reaction | 106 | 0.8% |
The reporter fills in the indication, and the field is often empty. Each share is of all 12,863 reports.
Drugs in the same reports
| Drug | Reports that name the two |
|---|---|
| Albuterol | 1,498 |
| Albuterol sulfate | 1,747 |
| Cetirizine | 930 |
| Omalizumab | 1,118 |
| Prednisone | 2,004 |
| Salbutamol | 1,173 |
| Singulair | 943 |
| Symbicort | 1,114 |
| Tiotropium bromide | 1,211 |
| Xolair | 931 |
The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.
FDA says:
Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
Pages near this one
- Montelukast sodium same ingredient
- Singulair same ingredient
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- Monoferric next in the A to Z list
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- Monjuvi next in the A to Z list
- Mopral next in the A to Z list
- Monistat-1 Vag Oint 6 5% next in the A to Z list
- Morniflumate next in the A to Z list
- Monistat 3 Combination Pack next in the A to Z list
- Morphabond Er next in the A to Z list
- Monistat 1 Combination Pack Triple Action next in the A to Z list
These links are for navigation. No count selected them. The class page lists each drug of the class.
Official pages
- DailyMed labels for MontelukastThe labels (prescribing information) that have this name, at the National Library of Medicine.
- MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
- MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
- FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.
The site checked these addresses on . The links open in a new tab.
Cite this page
Reported Reactions. Montelukast: adverse event reports that FDA received. https://reportedreactions.com/drug/montelukast/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .
Where the data come from
The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.
A report is in the count when it names Montelukast as a suspect or interacting product. The 44,459 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.
Questions
Do these reports show that Montelukast was responsible for the reactions?
No. FDA says:
For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .
A reaction can relate to the condition that the drug treats, to other medicines, or to something else.
Is this the list of reactions on the label of Montelukast?
No. It is a count of what people reported to FDA: 12,863 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.
Who sent these reports?
Consumer or non-health professional (40.9%), other health professional (29.5%) and physician (21.9%). These are the types of reporter for the reports that name this drug.
If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on .
How does a person report an adverse event?
FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.