72/100 · Elevated
Manufactured by Organon LLC
Montelukast Sodium Adverse Events: High Seriousness and Diverse Reactions
305,313 FDA adverse event reports analyzed
Last updated: 2026-05-12
MONTELUKAST SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. Based on analysis of 305,313 FDA adverse event reports, MONTELUKAST SODIUM 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 SODIUM include ASTHMA, DYSPNOEA, DRUG INEFFECTIVE, COUGH, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MONTELUKAST SODIUM.
Montelukast Sodium 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 305,313 adverse event reports for this medication, which is primarily manufactured by Organon Llc.
The most commonly reported adverse events include Asthma, Dyspnoea, Drug Ineffective. Of classified reports, 60.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with a high percentage of reports involving respiratory issues.
A wide variety of reactions are reported, indicating a complex safety profile. The drug is frequently reported to be ineffective, suggesting potential issues with efficacy. There is a notable number of reports related to mental health issues, including anxiety and depression. Reports of weight changes, both increase and decrease, are common, indicating potential metabolic effects.
Patients taking Montelukast Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Montelukast sodium may interact with other drugs, and patients should be aware of potential side effects and consult their healthcare provider before combining with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Montelukast Sodium received a safety concern score of 72/100 (elevated concern). This is based on a 60.9% serious event ratio across 116,883 classified reports. The score accounts for 305,313 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: 78,334, Male: 31,199, Unknown: 186. The most frequently reported age groups are age 65 (2,153 reports), age 60 (1,794 reports), age 58 (1,744 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 116,883 classified reports for MONTELUKAST SODIUM:
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 sodium may interact with other drugs, and patients should be aware of potential side effects and consult their healthcare provider before combining with other medications.
If you are taking Montelukast Sodium, here are important things to know. The most commonly reported side effects include asthma, dyspnoea, drug ineffective, cough, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for respiratory symptoms and seek medical attention if they worsen. Report any unusual or severe side effects to the FDA's MedWatch program. 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 the safety of montelukast sodium, and regulatory actions may be taken based on ongoing data analysis.
The FDA has received approximately 305,313 adverse event reports associated with Montelukast Sodium. 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 Sodium include Asthma, Dyspnoea, Drug Ineffective, Cough, Fatigue. By volume, the top reported reactions are: Asthma (14,472 reports), Dyspnoea (14,343 reports), Drug Ineffective (8,862 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 Sodium.
Out of 116,883 classified reports, 71,200 (60.9%) were classified as serious and 45,683 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 Sodium break down by patient sex as follows: Female: 78,334, Male: 31,199, Unknown: 186. 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 Sodium adverse events are: age 65: 2,153 reports, age 60: 1,794 reports, age 58: 1,744 reports, age 61: 1,707 reports, age 62: 1,693 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 Sodium adverse event reports is Organon Llc. 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 Sodium include: Headache, Wheezing, Pneumonia, Nausea, 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 Sodium 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 Sodium 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. The majority of adverse events are serious, with a high percentage of reports involving respiratory issues.
Key safety signals identified in Montelukast Sodium's adverse event data include: High percentage of serious adverse events (60.9%). Respiratory issues are the most common reactions, including asthma, wheezing, and pneumonia. Mental health issues such as anxiety and depression are frequently reported. Weight changes (both increase and decrease) are commonly reported. Drug ineffectiveness is a significant concern. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Montelukast sodium may interact with other drugs, and patients should be aware of potential side effects and consult their healthcare provider before combining with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Montelukast Sodium.
Monitor for respiratory symptoms and seek medical attention if they worsen. Report any unusual or severe side effects to the FDA's MedWatch program.
Montelukast Sodium has 305,313 adverse event reports on file with the FDA. A wide variety of reactions are reported, indicating a complex safety profile. The volume of reports for Montelukast Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of montelukast sodium, and regulatory actions may be taken based on ongoing data analysis. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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