72/100 · Elevated
Manufactured by Ajanta Pharma USA Inc.
Montelukast Adverse Events Show High Seriousness and Diverse Reactions
183,733 FDA adverse event reports analyzed
Last updated: 2026-05-12
MONTELUKAST is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Ajanta Pharma USA Inc.. Based on analysis of 183,733 FDA adverse event reports, MONTELUKAST has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for MONTELUKAST include DYSPNOEA, ASTHMA, DRUG INEFFECTIVE, FATIGUE, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MONTELUKAST.
Montelukast has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 183,733 adverse event reports for this medication, which is primarily manufactured by Ajanta Pharma Usa Inc..
The most commonly reported adverse events include Dyspnoea, Asthma, Drug Ineffective. Of classified reports, 65.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Montelukast reports show a high percentage of serious adverse events (65.3%), indicating significant safety concerns.
The most common reactions include dyspnea, asthma, and drug ineffectiveness, suggesting potential respiratory and efficacy issues. A wide range of reactions are reported, from respiratory issues to psychiatric effects, indicating a diverse safety profile.
Patients taking Montelukast should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Montelukast has been associated with serious respiratory issues and drug ineffectiveness, and patients should be monitored for these conditions. There are also warnings about off-label use and product dose issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Montelukast received a safety concern score of 72/100 (elevated concern). This is based on a 65.3% serious event ratio across 78,296 classified reports. The score accounts for 183,733 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 48,240, Male: 23,176, Unknown: 62. The most frequently reported age groups are age 65 (1,439 reports), age 62 (1,233 reports), age 54 (1,227 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 78,296 classified reports for MONTELUKAST:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Montelukast has been associated with serious respiratory issues and drug ineffectiveness, and patients should be monitored for these conditions. There are also warnings about off-label use and product dose issues.
If you are taking Montelukast, here are important things to know. The most commonly reported side effects include dyspnoea, asthma, drug ineffective, fatigue, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for serious respiratory issues and drug ineffectiveness, especially in elderly patients. Follow approved dosing and usage guidelines to avoid product dose issues and off-label use. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor Montelukast for safety, and healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 183,733 adverse event reports associated with Montelukast. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Montelukast include Dyspnoea, Asthma, Drug Ineffective, Fatigue, Headache. By volume, the top reported reactions are: Dyspnoea (7,723 reports), Asthma (7,440 reports), Drug Ineffective (5,932 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Montelukast.
Out of 78,296 classified reports, 51,098 (65.3%) were classified as serious and 27,198 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Montelukast break down by patient sex as follows: Female: 48,240, Male: 23,176, Unknown: 62. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Montelukast adverse events are: age 65: 1,439 reports, age 62: 1,233 reports, age 54: 1,227 reports, age 60: 1,209 reports, age 63: 1,151 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Montelukast adverse event reports is Ajanta Pharma Usa Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Montelukast include: Cough, Nausea, Off Label Use, Pneumonia, Pain. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Montelukast to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Montelukast has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Montelukast reports show a high percentage of serious adverse events (65.3%), indicating significant safety concerns.
Key safety signals identified in Montelukast's adverse event data include: High percentage of serious adverse events (65.3%). Common reactions include dyspnea, asthma, and drug ineffectiveness. Diverse range of reactions, including respiratory, psychiatric, and gastrointestinal issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Montelukast has been associated with serious respiratory issues and drug ineffectiveness, and patients should be monitored for these conditions. There are also warnings about off-label use and product dose issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Montelukast.
Monitor patients for serious respiratory issues and drug ineffectiveness, especially in elderly patients. Follow approved dosing and usage guidelines to avoid product dose issues and off-label use.
Montelukast has 183,733 adverse event reports on file with the FDA. The most common reactions include dyspnea, asthma, and drug ineffectiveness, suggesting potential respiratory and efficacy issues. The volume of reports for Montelukast reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Montelukast for safety, and healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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