ADVERSE REACTIONS
Adverse events reported in >1% of patients receiving AccuNeb and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table.
Table 1: Adverse Events with an Incidence of >1% of Patients Receiving AccuNeb and Greater than Placebo (expressed as % of treatment group) | 1.25 mg AccuNeb (N=115) | 0.63 mg AccuNeb (N=117) | Placebo (N=117) |
Asthma Exacerbation | 13 | 11.1 | 8.5 |
Otitis Media | 4.3 | 0.9 | 0 |
Allergic Reaction | 0.9 | 3.4 | 1.7 |
Gastroenteritis | 0.9 | 3.4 | 0.9 |
Cold Symptoms | 0 | 3.4 | 1.7 |
Flu Syndrome | 2.6 | 2.6 | 1.7 |
Lymphadenopathy | 2.6 | 0.9 | 1.7 |
Skin/Appendage Infection | 1.7 | 0 | 0 |
Urticaria | 1.7 | 0.9 | 0 |
Migraine | 0.9 | 1.7 | 0 |
Chest Pain | 0.9 | 1.7 | 0 |
Bronchitis | 0.9 | 1.7 | 0.9 |
Nausea | 1.7 | 0.9 | 0.9 |
There was one case of ST segment depression in the 1.25 mg AccuNeb treatment group.
No clinically relevant laboratory abnormalities related to AccuNeb administration were seen in this study.
|