FLUNISOLIDE NASAL SOLUTION SIDE EFFECTS

SIDE EFFECTS

The adverse events rates listed below are based on symptoms spontaneously reported in multidose controlled clinical trials in comparing flunisolide nasal solution (29 mcg per spray) and flunisolide nasal solution (flunisolide nasal spray .025%) (25 mcg per spray) for treatment of allergic rhinitis. In patients receiving flunisolide nasal solution (flunisolide nasal spray .025%) the most common adverse events were transient aftertaste (17%) and transient nasal burning and stinging (13%). These symptoms did not usually interfere with treatment.

Adverse Event Rates for Flunisolide Nasal Solution (flunisolide nasal spray .025%) (29 mcg per spray)

Incidence Greater than 1% (probably casually related)

Respiratory: Nasal burning/stinging (13%), epistaxis*, nasal dryness, pharyngitis, cough increased

Gastrointestinal: Nausea

Special Senses: Aftertaste (17%)

Incidence 1% or Less (probably casually related)

Respiratory: Hoarseness

Special Senses: Abnormal sense of smell

Incidence 1% or Less (casual relationship unknown)+

Respiratory: Sinusitis

Adverse Event Rates for Flunisolide Nasal Solution (flunisolide nasal spray .025%) (25 mcg per spray)

Incidence Greater than 1% (probably casually related)

Respiratory: Nasal burning/stinging (44%), epistaxis*, nasal dryness*, pharyngitis*, cough increased

Gastrointestinal: Nausea

Special Senses: Aftertaste (8%)

Incidence 1% or Less (probably casually related)

Respiratory: Hoarseness, nasal ulcer

Incidence 1% or Less (casual relationship unknown)+

Respiratory: Sinusitis

* Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients are unmarked.
+ Reactions occurred under circumstances where the casual relationship has not been clearly established; they are presented as alerting information for physicians.

Cases of growth suppression have been reported for intranasal corticosteroids (including flunisolide nasal solution).