FLUTICASONE FUROATE

N/A

Manufactured by GlaxoSmithKline LLC

35,585 FDA adverse event reports analyzed

Last updated: 2026-04-14

About FLUTICASONE FUROATE

FLUTICASONE FUROATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by GlaxoSmithKline LLC. The most commonly reported adverse reactions for FLUTICASONE FUROATE include DRUG INEFFECTIVE, DYSPNOEA, ASTHMA, OFF LABEL USE, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUTICASONE FUROATE.

Top Adverse Reactions

DRUG INEFFECTIVE1,994 reports
DYSPNOEA1,498 reports
ASTHMA1,252 reports
OFF LABEL USE984 reports
COUGH871 reports
WHEEZING852 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE759 reports
PRODUCT USE IN UNAPPROVED INDICATION690 reports
HEADACHE668 reports
NAUSEA668 reports
PAIN653 reports
MACULAR DEGENERATION620 reports
MALAISE616 reports
PNEUMONIA568 reports
FATIGUE552 reports
CONDITION AGGRAVATED541 reports
VOMITING540 reports
PRODUCT COMPLAINT496 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS458 reports
WEIGHT DECREASED444 reports
ABDOMINAL PAIN440 reports
PYREXIA396 reports
DIZZINESS393 reports
GASTROOESOPHAGEAL REFLUX DISEASE393 reports
NASAL CONGESTION384 reports
CONSTIPATION377 reports
OBSTRUCTIVE AIRWAYS DISORDER365 reports
RHINORRHOEA361 reports
PRODUCT DOSE OMISSION ISSUE355 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES349 reports
PRODUCTIVE COUGH346 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE345 reports
DIARRHOEA341 reports
SINUSITIS339 reports
ARTHRALGIA336 reports
CHEST DISCOMFORT325 reports
HYPERTENSION325 reports
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION322 reports
FULL BLOOD COUNT ABNORMAL311 reports
DRUG INTOLERANCE299 reports
DRUG HYPERSENSITIVITY293 reports
ABDOMINAL PAIN UPPER287 reports
PRURITUS284 reports
CHEST PAIN281 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION279 reports
DYSPEPSIA278 reports
NASOPHARYNGITIS278 reports
ANXIETY270 reports
ASTHENIA268 reports
RASH260 reports
ANAEMIA258 reports
PARAESTHESIA256 reports
HYPOAESTHESIA248 reports
MIGRAINE248 reports
INSOMNIA247 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS247 reports
HYPERSENSITIVITY240 reports
CHRONIC SINUSITIS236 reports
ERYTHEMA236 reports
WEIGHT INCREASED234 reports
DYSPNOEA EXERTIONAL230 reports
INFUSION RELATED REACTION226 reports
SOMNOLENCE225 reports
SLEEP DISORDER224 reports
DRY MOUTH218 reports
STRESS218 reports
BACK PAIN214 reports
ECZEMA209 reports
ABDOMINAL DISTENSION207 reports
PRODUCT USE ISSUE207 reports
EPISTAXIS206 reports
PAIN IN EXTREMITY206 reports
MEMORY IMPAIRMENT205 reports
FALL203 reports
COVID 19200 reports
GENERAL PHYSICAL HEALTH DETERIORATION194 reports
PRODUCT QUALITY ISSUE191 reports
DIABETES MELLITUS189 reports
DEPRESSION187 reports
ILLNESS187 reports
BRONCHITIS186 reports
INCORRECT DOSE ADMINISTERED184 reports
INFLUENZA183 reports
OROPHARYNGEAL PAIN181 reports
PARAESTHESIA ORAL180 reports
SEPSIS178 reports
PERIPHERAL SWELLING177 reports
DYSPHONIA173 reports
DEATH172 reports
TASTE DISORDER170 reports
EPILEPSY168 reports
BLOOD PRESSURE INCREASED166 reports
URTICARIA166 reports
BLEPHAROSPASM163 reports
PROCEDURAL PAIN163 reports
LOWER RESPIRATORY TRACT INFECTION160 reports
RESPIRATORY DISORDER155 reports
SWELLING155 reports
HYPONATRAEMIA154 reports
ORAL CANDIDIASIS151 reports

Report Outcomes

Out of 11,387 classified reports for FLUTICASONE FUROATE:

Serious 57.6%Non-Serious 42.4%

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 Breakdown

Reports by Sex

Female6,286 (66.1%)
Male3,211 (33.8%)
Unknown11 (0.1%)

Reports by Age

Age 80231 reports
Age 71203 reports
Age 43202 reports
Age 65202 reports
Age 74170 reports
Age 60149 reports
Age 63140 reports
Age 62138 reports
Age 68138 reports
Age 69134 reports
Age 61131 reports
Age 78130 reports
Age 66128 reports
Age 56125 reports
Age 73123 reports
Age 72121 reports
Age 75121 reports
Age 57120 reports
Age 70120 reports
Age 45116 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with FLUTICASONE FUROATE?

This profile reflects 35,585 FDA FAERS reports that mention FLUTICASONE FUROATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FLUTICASONE FUROATE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DYSPNOEA, ASTHMA, OFF LABEL USE, COUGH, WHEEZING. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures FLUTICASONE FUROATE?

Labeling and FAERS entries often list GlaxoSmithKline LLC in connection with FLUTICASONE FUROATE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.