SIDE EFFECTS
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.
