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Nasarel (Flunisolide Nasal) - Side Effects and Adverse Reactions

 
 



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) [ Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients] Respiratory: Sinusitis

Adverse Event Rates for NASALIDE:

Incidence Greater than 1% (probably casually related)

Respiratory: Nasal burning/stinging (44%), epistaxis [ Reactions occurred under circumstances where the casual relationship has not been clearly established; they are presented as alerting information for physicians] , 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).

Drug label data at the top of this Page last updated: 2006-10-09

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