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Adverse events reported in > 1% of patients receiving albuterol sulfate (albuterol sulfate inhalation solution) 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 Albuterol Sulfate (albuterol sulfate inhalation solution) and Greater than Placebo (expressed as % of treatment group)

  1.25 mg
Albuterol Sulfate (albuterol sulfate inhalation solution)
(N=115)
0.63 mg
Albuterol Sulfate (albuterol sulfate inhalation solution)
(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 albuterol sulfate (albuterol sulfate inhalation solution) treatment group.

No clinically relevant laboratory abnormalities related to albuterol sulfate (albuterol sulfate inhalation solution) administration were seen in this study.