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Allernaze

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Allernaze

Allernaze

Allernaze Side Effects Center

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Allernaze FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In adequate, well-controlled and uncontrolled studies, 1187 patients have received triamcinolone acetonide solution. The adverse reactions summarized below, are based upon seven placebo controlled clinical trials of 2-6 weeks duration in 847 patients with seasonal or perennial allergic rhinitis (504 patients received 200 mcg or 400 mcg per day of triamcinolone acetonide solution and 343 patients received vehicle placebo). Adverse events reported by 2% or more of patients (regardless of relationship to treatment) who received triamcinolone acetonide solution 200 or 400 mcg once daily and that were more common with triamcinolone acetonide solution than with placebo are displayed in the table below. Overall, the incidence and nature of adverse events with triamcinolone acetonide solution 400 mcg was comparable to that seen with triamcinolone acetonide solution 200 mcg and with vehicle placebo.

ADVERSE EVENTS REPORTED AT A FREQUENCY OF 2% OR GREATER AND MORE COMMON AMONG PATIENTS TREATED WITH triamcinolone acetonide solution THAN PLACEBO REGARDLESS OF RELATIONSHIP TO TREATMENT

ADVERSE EVENTS 200 mcg of
triamcinolone
acetonide
once daily
n = 204
400 mcg of
triamcinolone
acetonide
once daily
n = 300
Combined
(200 and 400 mcg)
use of triamcinolone
acetonide
n = 504
Vehicle
Placebo
n = 343
BODY AS A WHOLE
Headache 51.0% 44.3% 47.0% 41.1%
Back Pain 7.8% 4.7% 6.0% 3.5%
RESPIRATORY SYSTEM
Pharyngitis 13.7% 10.3% 11.7% 7.9%
Asthma 5.4% 4.3% 4.8% 2.9%
Cough Increased 2.0% 2.7% 2.4% 2.3%
DIGESTIVE SYSTEM
Dyspepsia 4.9% 2.7% 3.6% 2.0%
Nausea 2.0% 3.0% 2.6% 0.6%
Vomiting 1.5% 2.7% 2.2% 1.5%
SPECIAL SENSES
Taste Perversion 7.8% 5.0% 6.2% 2.9%
Conjunctivitis 4.4% 1.3% 2.6% 1.5%
MUSCULOSKELETAL SYSTEM
Myalgia 2.5% 3.3% 3.0% 2.6%

Adverse events reported by 2% or more of patients who received triamcinolone acetonide solution 200 or 400 mcg once daily and that were more common with placebo than with triamcinolone acetonide solution included: application site reaction (e.g. transient nasal burning and stinging), rhinitis, dysmenorrhea, pain (unspecified) and allergic reaction.

The adverse effects related to the irritation of nasal mucous membranes (i.e. application site reaction) did not usually interfere with treatment. In the controlled and uncontrolled studies, approximately 0.3% of patients discontinued because of irritation of nasal mucous membranes.

Read the entire FDA prescribing information for Allernaze (Triamcinolone Acetonide Nasal Spray) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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