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Flovent - Side Effects & Drug Interactions

[Fluticasone Propionate]



Gastrointestinal
Nausea and vomiting, diarrhea, dyspepsia and stomach disorder.

Miscellaneous Fever.

Mouth and Teeth
Dental problem.

Musculoskeletal
Pain in joint, sprain/ strain, aches and pains, pain in limb.

Neurological
Dizziness/ giddiness.

Respiratory
Bronchitis, chest congestion.

Skin
Dermatitis, rash/ skin eruption.

Urogenital
Dysmenorrhea.

In a 16-week study in patients with asthma requiring oral corticosteroids, the effects of FLOVENT Inhalation Aerosol, 660 mcg twice daily (N = 32) and 880 mcg twice daily (N = 32), were compared with placebo. Adverse events (whether considered drug-related or nondrug-related by the investigator) reported by more than 3 patients in either group treated with FLOVENT Inhalation Aerosol and that were more common with FLOVENT than placebo are shown below:

Ear, Nose, and Throat:

Pharyngitis (9% and 25%),
nasal congestion (19% and 22%),
sinusitis (19% and 22%),
nasal discharge (16% and 16%),
dysphonia (19% and 9%),
pain in nasal sinus( es) (13% and 0%),
Candida-like oral lesions (16% and 9%),
oropharyngeal candidiasis (25% and 19%).

Respiratory:

Upper respiratory infection (31% and 19%),
influenza (0% and 13%).

Other:

Headache (28% and 34%),
pain in joint (19% and 13%),
nausea and vomiting (22% and 16%),
muscular soreness (22% and 13%),
malaise/ fatigue (22% and 28%),
insomnia (3% and 13%).

Observed During Clinical Practice:

In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of fluticasone propionate. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.
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