65/100 · Elevated
Manufactured by Haleon US Holdings LLC
Fluticasone Propionate Adverse Events: Moderate Safety Concerns
187,924 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUTICASONE PROPIONATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. Based on analysis of 187,924 FDA adverse event reports, FLUTICASONE PROPIONATE 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 include DRUG INEFFECTIVE, HEADACHE, FATIGUE, DYSPNOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUTICASONE PROPIONATE.
Fluticasone Propionate 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 187,924 adverse event reports for this medication, which is primarily manufactured by Haleon Us Holdings Llc.
The most commonly reported adverse events include Drug Ineffective, Headache, Fatigue. Of classified reports, 47.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common adverse reactions include headache, fatigue, and dyspnea, indicating potential respiratory and neurological effects.
Serious adverse events, such as pneumonia and death, are reported but at a lower frequency compared to non-serious events. There is a notable trend of drug ineffectiveness and off-label use, suggesting potential misuse or inefficacy issues. The majority of reports are from adults, with a significant number of serious events reported in the elderly.
Patients taking Fluticasone Propionate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Fluticasone Propionate can interact with other corticosteroids and may exacerbate existing conditions like hypertension and diabetes. Warnings include potential for serious respiratory issues and death. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fluticasone Propionate received a safety concern score of 65/100 (elevated concern). This is based on a 47.8% serious event ratio across 90,209 classified reports. The score accounts for 187,924 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: 55,179, Male: 27,555, Unknown: 79. The most frequently reported age groups are age 65 (1,312 reports), age 60 (1,310 reports), age 63 (1,208 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 90,209 classified reports for FLUTICASONE PROPIONATE:
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.
Fluticasone Propionate can interact with other corticosteroids and may exacerbate existing conditions like hypertension and diabetes. Warnings include potential for serious respiratory issues and death.
If you are taking Fluticasone Propionate, here are important things to know. The most commonly reported side effects include drug ineffective, headache, fatigue, dyspnoea, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any serious adverse events immediately to their healthcare provider. Follow prescribed dosing instructions and do not use the drug for off-label purposes. 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, with ongoing reviews of serious adverse events. Healthcare providers should be vigilant and consider patient age and health status when prescribing.
The FDA has received approximately 187,924 adverse event reports associated with Fluticasone Propionate. 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 include Drug Ineffective, Headache, Fatigue, Dyspnoea, Nausea. By volume, the top reported reactions are: Drug Ineffective (7,582 reports), Headache (6,061 reports), Fatigue (5,937 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.
Out of 90,209 classified reports, 43,143 (47.8%) were classified as serious and 47,066 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 break down by patient sex as follows: Female: 55,179, Male: 27,555, Unknown: 79. 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 adverse events are: age 65: 1,312 reports, age 60: 1,310 reports, age 63: 1,208 reports, age 70: 1,204 reports, age 62: 1,198 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 adverse event reports is Haleon Us Holdings 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 Fluticasone Propionate include: Pain, Diarrhoea, Off Label Use, Cough, Dizziness. 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 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 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 adverse reactions include headache, fatigue, and dyspnea, indicating potential respiratory and neurological effects.
Key safety signals identified in Fluticasone Propionate's adverse event data include: Pneumonia and death are key serious safety signals, indicating potential respiratory risks.. Drug ineffectiveness and off-label use suggest misuse or inefficacy issues.. Headache, fatigue, and dyspnea are frequent, indicating potential neurological and respiratory side effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Fluticasone Propionate can interact with other corticosteroids and may exacerbate existing conditions like hypertension and diabetes. Warnings include potential for serious respiratory issues and death. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fluticasone Propionate.
Patients should report any serious adverse events immediately to their healthcare provider. Follow prescribed dosing instructions and do not use the drug for off-label purposes.
Fluticasone Propionate has 187,924 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and death, are reported but at a lower frequency compared to non-serious events. The volume of reports for Fluticasone Propionate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Fluticasone Propionate, with ongoing reviews of serious adverse events. Healthcare providers should be vigilant and consider patient age and health status when prescribing. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Haleon US Holdings LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with FLUTICASONE PROPIONATE:
Drugs related to FLUTICASONE PROPIONATE based on therapeutic use, drug class, or shared indications: