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Serevent Diskus

[Salmeterol]

Neurology:

Migraines. Non-Site Specific: Pain, edema and swelling.

Psychiatry:

Text Continues Below



Anxiety.

Skin:

Skin rashes.

Observed During Clinical Practice:

In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of salmeterol. 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 either their seriousness, frequency of reporting, or causal connection to salmeterol or a combination of these factors.

In extensive US and worldwide postmarketing experience with salmeterol, 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 also occurred in a few patients with less severe asthma. It was not possible from these reports to determine whether salmeterol contributed to these events or simply failed to relieve the deteriorating asthma.

Respiratory:

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

Cardiovascular:

Arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), and anaphylaxis.

Non-Site Specific:

Very rare anaphylactic reaction in patients with severe milk protein allergy.

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