ADVERSE REACTIONS:
The adverse events rates listed below are based on symptoms spontaneously reported in multidose controlled clinical trails in comparing NASAREL and NASALIDE for treatment of allergic rhinitis. In patients receiving NASAREL 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 NASAREL:
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 NASALIDE:
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
Cases of growth suppression have been reported for intranasal corticosteroids (including NASAREL) (see PRECAUTIONS, Pediatric Use section).
|