ALLERNAZE SIDE EFFECTS
- Generic Name: triamcinolone acetonide nasal spray
- Brand Name: Allernaze
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.
SRC: NLM .