ADVERSE REACTIONS
Clinical Trials
A total of 1176 patients with allergic rhinitis were enrolled in placebo-controlled and open-label clinical studies of Nasacort HFA Nasal Aerosol.
In the placebo-controlled trial, 220 patients were treated with Nasacort HFA Nasal Aerosol for an average of 15 days (range 1–19 days). No changes in mucous membranes were noted from physical and visual examinations during this trial.
Adverse events occurring with an incidence of 3% or greater and more commonly with Nasacort HFA Nasal Aerosol arms compared to placebo irrespective of drug relationship are presented in the following table:
| Adverse Event | Nasacort HFA Nasal Aerosol
110 mcg
(n=107) % | Nasacort HFA Nasal Aerosol
440 mcg
(n=113) % | Placebo
(n=111) % |
|---|
| Sneezing | 14.0 | 15.9 | 7.2 |
| Headache | 10.3 | 6.2 | 8.1 |
| Nasal irritation | 7.5 | 6.2 | 3.6 |
| Rhinitis | 4.7 | 3.5 | 1.8 |
Of the 396 patients enrolled in the 12-month open-label study, 75% received treatment for greater than 6 months. In this study, patients were treated with Nasacort HFA Nasal Aerosol at 220 mcg once daily for the first 2 weeks and 440 mcg once daily for remainder of the study. Adverse events that were considered possibly or probably related to Nasacort HFA Nasal Aerosol and reported at an incidence of 3% or greater included: headache, epistaxis, nasal septum discomfort, rhinitis, nasal burning, and sneezing.
In the open-label study only 2% of patients receiving recommended doses discontinued due to nasal adverse effects. In the rest of the patients the nasal adverse events usually did not interfere with treatment. Seven of the 18 patients who reported nasal septum discomfort had objective evidence of ulceration, abrasion, erosion, or excoriation of the nasal septum, and 22 of the 396 (5.5%) enrolled patients developed nasal septum disorders, of whom 8 had evidence of ulceration, erosion, or excoriation of the septum, and 14 had epistaxis. It is advisable for patients who experience nasal septum discomfort to re-evaluate their technique in the application of Nasacort HFA Nasal Aerosol to minimize deposition of drug onto the septum.
If recommended doses are exceeded, or if individuals taking Nasacort HFA Nasal Aerosol are particularly sensitive or take the drug in conjunction with other corticosteroids, symptoms of hypercorticism, e.g., Cushing syndrome, could occur.
In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but systemic adverse experiences are unlikely (see OVERDOSAGE).
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during use of Nasacort Nasal Inhaler (triamcinolone acetonide CFC formulation) in clinical practice: nasal septal perforation, infection of the nose and pharynx with Candida albicans, cataracts, glaucoma, increased intraocular pressure, wheezing, rash, pruritus, urticaria, dizziness, paresthesia, dry mouth, nausea, coughing, dyspnea, and allergic reaction. Because they were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or possible causal connection to triamcinolone acetonide or a combination of these factors.
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