Nasacort Side Effects

Please note - some side effects for Nasacort 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 Nasacort - for the consumer

Nasacort AQ 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 Nasacort AQ Spray:

Cough; nosebleed; sore throat.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); muscle weakness; nasal discomfort; repeated nosebleeds; unusual or persistent stomach upset; unusual weight gain, especially in the face; white patches in the mouth.

For the professional

Nasacort

Adults and Children 12 years of age and older

In controlled and uncontrolled studies, 1257 adult and adolescent patients received treatment with intranasal triamcinolone acetonide. Adverse reactions are based on the 567 patients who received a product similar to the marketed Nasacort canister.

These patients were treated for an average of 48 days (range 1 to 117 days). The 145 patients enrolled in uncontrolled studies received treatment from 1 to 820 days (average 332 days). The most prevalent adverse experience was headache, being reported by approximately 18% of the patients who received Nasacort. Nasal irritation was reported by 2.8% of the patients receiving Nasacort. Other nasopharyngeal side effects were reported by fewer than 5% of the patients who received Nasacort and included: dry mucous membranes, naso-sinus congestion, throat discomfort, sneezing, and epistaxis. The complaints do not usually interfere with treatment and in the controlled and uncontrolled studies approximately 1% of patients have discontinued because of these nasal adverse effects. In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but systemic adverse experiences are unlikely.

Children 6 through 11 years of age

Adverse event data in children 6 through 11 years of age are derived from two controlled clinical trials of two and four weeks duration. In these trials, 127 patients received fixed doses of 220 mcg/day of triamcinolone acetonide for an average of 22 days (range 8 to 33 days).

Adverse events occurring at an incidence of 3% or greater and more common among children treated with 220 mcg triamcinolone acetonide daily than vehicle placebo were:

Adverse events occurring at a rate of 3% or greater that were more common in the placebo group were upper respiratory tract infection, headache and concurrent infection.

Only 1.6% of patients discontinued due to adverse experiences. No patient discontinued due to a serious adverse event related to Nasacort therapy.

Though not observed in controlled clinical trials of Nasacort Nasal Inhaler in children, cases of nasal septum perforation among pediatric users have been reported in post-marketing surveillance of this product.

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