Table 2.
Adverse events in placebo-controlled clinical trials of fluticasone furoate in patients with seasonal or perennial allergic rhinitis15
|
Adolescents and adults age ≥ 12 years in trials lasting 2–6 weeks | ||
|---|---|---|
|
Fluticasone furoate |
Placebo |
|
|
110 μg n = 768 |
n = 774 | |
| n (%) | n (%) | |
| Headache | 72 (9) | 54 (7) |
| Epistaxis | 45 (6) | 32 (4) |
| Pharyngolaryngeal pain | 15 (2) | 8 (1) |
| Nasal ulceration | 11 (1) | 3 (<1) |
| Back pain | 9 (1) | 7 (<1) |
|
Pediatric patients aged 2–12 years in trials lasting 2–12 weeks | |||
|---|---|---|---|
|
Fluticasone furoate |
Placebo |
||
|
55 μg n = 369 |
110 μg n = 426 |
n = 429 | |
| n (%) | n (%) | n (%) | |
| Headache | 28 (8) | 33 (8) | 31 (7) |
| Nasopharyngitis | 20 (5) | 21 (5) | 21 (5) |
| Epistaxis | 17 (5) | 17 (4) | 19 (4) |
| Pyrexia | 17 (5) | 19 (4) | 7 (2) |
| Pharyngolaryngeal pain | 16 (4) | 12 (3) | 14 (3) |
| Cough | 12 (3) | 16 (4) | 12 (3) |