Nasarel Side Effects

Please note - some side effects for Nasarel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nasarel - for the Consumer

Nasarel Spray

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nasarel Spray:

Aftertaste; cough; nasal burning, dryness, or stinging; nausea; nosebleed; sore throat.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sense of smell; excessive sneezing; muscle weakness; nasal discomfort or irritation; repeated nosebleeds; unusual weight gain, especially in the face; white patches in the mouth, nose, or throat.

Nasarel Side Effects - for the Professional

Nasarel

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%), epistaxis2, 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)1Respiratory: Sinusitis

Adverse Event Rates for NASALIDE:

Incidence Greater than 1% (probably casually related)

Respiratory: Nasal burning/stinging (44%), epistaxis2, nasal dryness2, pharyngitis2, 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)1Respiratory: Sinusitis

Cases of growth suppression have been reported for intranasal corticosteroids (including Nasarel).

1

Incidence of reported reaction between 3% and 9%. Those reactions occurring in less than 3% of the patients

2

Reactions occurred under circumstances where the casual relationship has not been clearly established; they are presented as alerting information for physicians

Side Effects by Body System

General

Flunisolide has been generally well tolerated and, due to its route of administration, has not been inclined to produce the adverse effects generally associated with systemic corticosteroids. The most frequent complaints have been related to nasal mucus membrane irritation.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting in less than 5% of patients. Bitterness and/or bad taste occurred more frequently.

Respiratory

Respiratory side effects have included nasal irritation, burning and stinging, congestion, epistaxis, sneezing, and rarely, nasal septal perforations. Temporary or permanent loss of the sense of smell and taste have occurred with both oral inhalation and intranasal formulations.

Nervous system

Nervous system side effects have been generally limited to headache, which occurred in less than 5% of patients.

Endocrine

Endocrine side effects have rarely included suppression of the hypothalamic-pituitary-adrenal axis. The risk of adrenal suppression has been less than that associated with systemic corticosteroids and was generally only of concern when using higher than recommended dosages or in patients who may be particularly sensitive.

Dermatologic

Dermatologic side effects have included rare reports of rash.

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