XHANCE Has Continued to Demonstrate a Consistent Safety Profile1
Adverse events occurring in ≥3% of patients and more common than placebo
| Adverse event, n (%) |
EDS-placebo BID (n=187) |
XHANCE 186 mcg BID (n=184) |
XHANCE 372 mcg BID (n=183) |
|---|---|---|---|
| Epistaxis | 1 (0.5) | 9 (4.9) | 20 (10.9) |
| Headache | 7 (3.7) | 4 (2.2) | 10 (5.5) |
| Nasopharyngitis | 8 (4.3) | 9 (4.9) | 7 (3.8) |
BID=twice daily.
| Adverse event, n (%) |
EDS-placebo BID (n=161) |
XHANCE 186 mcg BID (n=160) |
XHANCE 372 mcg BID (n=161) |
|---|---|---|---|
| Epistaxis* | 4 (2.5) | 19 (11.9) | 16 (9.9) |
| Nasopharyngitis | 8 (5.0) | 3 (1.9) | 12 (7.5) |
| Nasal septal ulceration† | 3 (1.9) | 11 (6.9) | 12 (7.5) |
| Nasal congestion | 6 (3.7) | 7 (4.4) | 9 (5.6) |
| Acute sinusitis | 6 (3.7) | 7 (4.4) | 8 (5.0) |
| Headache | 5 (3.1) | 8 (5.0) | 6 (3.7) |
| Pharyngitis | 2 (1.2) | 2 (1.3) | 5 (3.1) |
| Nasal mucosal ulceration | 2 (1.3) | 6 (3.8) | 4 (2.5) |
| Nasal mucosal erythema | 6 (3.7) | 9 (5.6) | 8 (5.0) |
| Nasal septal erythema | 3 (1.9) | 6 (3.8) | 7 (4.3) |
*Includes spontaneous adverse reaction reports.
†Includes ulcerations and erosions.
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