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Serevent Aerosol

[salmeterol xinafoate]

Observed During Clinical Practice

In extensive US and worldwide postmarketing experience, serious exacerbations of asthma, including some that have been fatal, have been reported. In most cases, these have occurred in patients with severe asthma and/or in some patients in whom asthma has been acutely deteriorating (see WARNINGS no. 1), but they have occurred in a few patients with less severe asthma as well. It was not possible from these reports to determine whether SEREVENT Inhalation Aerosol contributed to these events or simply failed to relieve the deteriorating asthma.

The following events have also been identified during postapproval use of SEREVENT in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to SEREVENT.

Text Continues Below



Respiratory

Rare reports of upper airway symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking; oropharyngeal irritation.

Cardiovascular

Hypertension, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles).


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