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The results of clinical trials with VENTOLIN Inhalation Solution in 135 patients showed the following side effects that were considered probably or possibly drug related:

Percent Incidence of Adverse Reactions

 

Percent Incidence

Reaction

n = 135

Central nervous system

 

Tremors

20%

Dizziness

7%

Nervousness

4%

Headache

3%

Sleeplessness

1%

Gastrointestinal

 

Nausea

4%

Dyspepsia

1%

Ear, nose, and throat

 

Nasal congestion

1%

Pharyngitis

<1%

Cardiovascular

 

Tachycardia

1%

Hypertension

1%

Respiratory

 

Bronchospasm

8%

Cough

4%

Bronchitis

4%

Wheezing

1%

No clinically relevant laboratory abnormalities related to VENTOLIN Inhalation Solution administration were determined in these studies.

Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported after the use of VENTOLIN Inhalation Solution.