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Nasacort (Triamcinolone Acetonide Nasal) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 (see OVERDOSAGE section).

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 Events220 mcg of
triamcinolone acetonide daily
(n=127)
Vehicle
placebo
(n=322)
Epistaxis11.0%9.3%
Cough9.4%9.3%
Fever7.9%5.6%
Nausea6.3%3.1%
Throat discomfort5.5%5.3%
Otitis4.7%3.7%
Dyspepsia4.7%2.2%

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.



REPORTS OF SUSPECTED NASACORT SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Nasacort. The information is not vetted and should not be considered as verified clinical evidence.

Possible Nasacort side effects / adverse reactions in 60 year old female

Reported by a consumer/non-health professional from United States on 2011-10-18

Patient: 60 year old female weighing 54.4 kg (119.7 pounds)

Reactions: OFF Label USE, Drug Dose Omission, Headache, Nasal Disorder

Suspect drug(s):
Symbicort
    Dosage: 80/40.5, 2 puff twice a day/bid
    Indication: Asthma
    Start date: 2009-01-01

Symbicort
    Dosage: 80/40.5, 1 puff twice a day/bid
    Start date: 2009-01-01

Nasacort



See index of all Nasacort side effect reports >>

Drug label data at the top of this Page last updated: 2007-09-11

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