65/100 · Elevated
Manufactured by L. Perrigo Company
Moderate Safety Concerns for Mometasone Furoate
107,848 FDA adverse event reports analyzed
Last updated: 2026-05-12
MOMETASONE FUROATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by L. Perrigo Company. Based on analysis of 107,848 FDA adverse event reports, MOMETASONE FUROATE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for MOMETASONE FUROATE include PRODUCT QUALITY ISSUE, NO ADVERSE EVENT, DYSPNOEA, DRUG DOSE OMISSION, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MOMETASONE FUROATE.
Mometasone Furoate has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 107,848 adverse event reports for this medication, which is primarily manufactured by L. Perrigo Company.
The most commonly reported adverse events include Product Quality Issue, No Adverse Event, Dyspnoea. Of classified reports, 55.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are non-serious, but serious events such as pneumonia and death are reported.
Common reactions include respiratory issues like wheezing and dyspnea, as well as gastrointestinal symptoms like nausea and diarrhea. There is a notable number of drug dose omission and quality issues reported.
Patients taking Mometasone Furoate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other corticosteroids may increase the risk of side effects. Patients should avoid using this drug with other corticosteroids without consulting a healthcare provider. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Mometasone Furoate received a safety concern score of 65/100 (elevated concern). This is based on a 55.9% serious event ratio across 40,089 classified reports. The score accounts for 107,848 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: 24,145, Male: 12,332, Unknown: 305. The most frequently reported age groups are age 64 (753 reports), age 54 (724 reports), age 57 (611 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 40,089 classified reports for MOMETASONE FUROATE:
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.
Interactions with other corticosteroids may increase the risk of side effects. Patients should avoid using this drug with other corticosteroids without consulting a healthcare provider.
If you are taking Mometasone Furoate, here are important things to know. The most commonly reported side effects include product quality issue, no adverse event, dyspnoea, drug dose omission, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed dosage and instructions carefully to minimize the risk of adverse events. Report any serious or persistent side effects to your healthcare provider immediately. 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 Mometasone Furoate. Healthcare providers should report any serious adverse events to the FDA's MedWatch program.
The FDA has received approximately 107,848 adverse event reports associated with Mometasone Furoate. 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 Mometasone Furoate include Product Quality Issue, No Adverse Event, Dyspnoea, Drug Dose Omission, Drug Ineffective. By volume, the top reported reactions are: Product Quality Issue (4,330 reports), No Adverse Event (4,323 reports), Dyspnoea (3,842 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Mometasone Furoate.
Out of 40,089 classified reports, 22,396 (55.9%) were classified as serious and 17,693 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 Mometasone Furoate break down by patient sex as follows: Female: 24,145, Male: 12,332, Unknown: 305. 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 Mometasone Furoate adverse events are: age 64: 753 reports, age 54: 724 reports, age 57: 611 reports, age 61: 530 reports, age 60: 525 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 Mometasone Furoate adverse event reports is L. Perrigo Company. 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 Mometasone Furoate include: Asthma, Headache, Cough, Fatigue, Nausea. 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 Mometasone Furoate 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.
Mometasone Furoate has a safety concern score of 65 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 non-serious, but serious events such as pneumonia and death are reported.
Key safety signals identified in Mometasone Furoate's adverse event data include: Serious adverse events like pneumonia and death are reported, indicating potential severe risks.. Respiratory issues are frequently reported, suggesting a need for careful monitoring in patients with respiratory conditions.. Drug dose omission and quality issues are common, highlighting the importance of proper dosing and product quality.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other corticosteroids may increase the risk of side effects. Patients should avoid using this drug with other corticosteroids without consulting a healthcare provider. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Mometasone Furoate.
Follow the prescribed dosage and instructions carefully to minimize the risk of adverse events. Report any serious or persistent side effects to your healthcare provider immediately.
Mometasone Furoate has 107,848 adverse event reports on file with the FDA. Common reactions include respiratory issues like wheezing and dyspnea, as well as gastrointestinal symptoms like nausea and diarrhea. The volume of reports for Mometasone Furoate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Mometasone Furoate. Healthcare providers should report any serious 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.
The following drugs share commonly reported adverse reactions with MOMETASONE FUROATE:
Drugs related to MOMETASONE FUROATE based on therapeutic use, drug class, or shared indications: