65/100 · Elevated
Manufactured by Advagen Pharma Ltd.
Moderate Safety Concerns with Fluticasone Propionate Nasal
70,865 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUTICASONE PROPIONATE NASAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Advagen Pharma Ltd.. Based on analysis of 70,865 FDA adverse event reports, FLUTICASONE PROPIONATE NASAL 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 FLUTICASONE PROPIONATE NASAL include DYSPNOEA, DRUG INEFFECTIVE, HEADACHE, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUTICASONE PROPIONATE NASAL.
Fluticasone Propionate Nasal 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 70,865 adverse event reports for this medication, which is primarily manufactured by Advagen Pharma Ltd..
The most commonly reported adverse events include Dyspnoea, Drug Ineffective, Headache. Of classified reports, 59.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include dyspnoea, drug ineffectiveness, and headache, indicating potential respiratory and systemic effects.
Serious reactions such as pneumonia, death, and infection are reported, though less frequently. A high number of adverse events are related to product misuse or incorrect use, highlighting the importance of proper administration. The majority of reactions are non-serious, but the diversity of reactions suggests a complex safety profile.
Patients taking Fluticasone Propionate Nasal should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Drug interactions are reported, and patients should be advised to inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fluticasone Propionate Nasal received a safety concern score of 65/100 (elevated concern). This is based on a 59.4% serious event ratio across 28,362 classified reports. The score accounts for 70,865 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: 16,861, Male: 9,190, Unknown: 33. The most frequently reported age groups are age 65 (504 reports), age 60 (433 reports), age 68 (417 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,362 classified reports for FLUTICASONE PROPIONATE NASAL:
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.
Drug interactions are reported, and patients should be advised to inform their healthcare provider of all medications they are taking.
If you are taking Fluticasone Propionate Nasal, here are important things to know. The most commonly reported side effects include dyspnoea, drug ineffective, headache, fatigue, off label use. 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 administration instructions carefully to avoid adverse reactions. Report any unusual symptoms to your healthcare provider promptly. 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 Fluticasone Propionate Nasal, and updates will be provided as necessary.
The FDA has received approximately 70,865 adverse event reports associated with Fluticasone Propionate Nasal. 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 Fluticasone Propionate Nasal include Dyspnoea, Drug Ineffective, Headache, Fatigue, Off Label Use. By volume, the top reported reactions are: Dyspnoea (2,272 reports), Drug Ineffective (2,237 reports), Headache (2,126 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Fluticasone Propionate Nasal.
Out of 28,362 classified reports, 16,838 (59.4%) were classified as serious and 11,524 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 Fluticasone Propionate Nasal break down by patient sex as follows: Female: 16,861, Male: 9,190, Unknown: 33. 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 Fluticasone Propionate Nasal adverse events are: age 65: 504 reports, age 60: 433 reports, age 68: 417 reports, age 70: 415 reports, age 66: 410 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 Fluticasone Propionate Nasal adverse event reports is Advagen Pharma Ltd.. 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 Fluticasone Propionate Nasal include: Pain, Nausea, Cough, Asthma, Diarrhoea. 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 Fluticasone Propionate Nasal 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.
Fluticasone Propionate Nasal 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 most common reactions include dyspnoea, drug ineffectiveness, and headache, indicating potential respiratory and systemic effects.
Key safety signals identified in Fluticasone Propionate Nasal's adverse event data include: Pneumonia and other respiratory infections are reported, raising concerns about potential immunosuppressive effects.. Death and serious infections are noted, indicating a need for careful monitoring, especially in elderly patients.. Product misuse and dose omission issues are frequent, suggesting a risk of underdosing or overdosing.. A wide range of reactions, including neurological and gastrointestinal symptoms, indicates a broad safety profile.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Drug interactions are reported, and patients should be advised to inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fluticasone Propionate Nasal.
Follow the prescribed dosage and administration instructions carefully to avoid adverse reactions. Report any unusual symptoms to your healthcare provider promptly.
Fluticasone Propionate Nasal has 70,865 adverse event reports on file with the FDA. Serious reactions such as pneumonia, death, and infection are reported, though less frequently. The volume of reports for Fluticasone Propionate Nasal reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Fluticasone Propionate Nasal, and updates will be provided as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Advagen Pharma Ltd. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with FLUTICASONE PROPIONATE NASAL:
Drugs related to FLUTICASONE PROPIONATE NASAL based on therapeutic use, drug class, or shared indications: