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Accuneb (Albuterol Sulfate Inhalation Solution) - Side Effects and Adverse Reactions

 
 



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 Exacerbation1311.18.5
Otitis Media4.30.90
Allergic Reaction0.93.41.7
Gastroenteritis0.93.40.9
Cold Symptoms03.41.7
Flu Syndrome2.62.61.7
Lymphadenopathy2.60.91.7
Skin/Appendage Infection1.700
Urticaria1.70.90
Migraine0.91.70
Chest Pain0.91.70
Bronchitis0.91.70.9
Nausea1.70.90.9

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.

Drug label data at the top of this Page last updated: 2008-06-27

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