 Table 4 includes all events (whether considered drug-related or nondrug-related by the investigator) that occurred at a rate of 3% or greater in the group receiving ADVAIR DISKUS 250/50 and were more common than in the placebo group. These adverse reactions were mostly mild to moderate in severity. Other adverse events that occurred in the groups receiving ADVAIR DISKUS 250/50 with an incidence of 1% to 3% and that occurred at a greater incidence than with placebo were: Cardiovascular Syncope. Drug Interaction, Overdose, and Trauma Postoperative complications. Ear, Nose, and Throat Ear, nose, and throat infections; ear signs and symptoms; laryngitis; nasal congestion/blockage; nasal sinus disorders; pharyngitis/throat infection. Endocrine and Metabolic Hypothyroidism. Eye Dry eyes, eye infections. Gastrointestinal Constipation, gastrointestinal signs and symptoms, oral lesions. Hepatobiliary Tract and Pancreas Abnormal liver function tests. Lower Respiratory Breathing disorders, lower respiratory signs and symptoms. Non-Site Specific Bacterial infections, candidiasis unspecified site, edema and swelling, nonspecific conditions, viral infections. Psychiatry Situational disorders. Observed During Clinical Practice In addition to adverse events reported from clinical trials, the following events have been identified during worldwide use of any formulation of ADVAIR, fluticasone propionate, and/or salmeterol regardless of indication. 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 ADVAIR DISKUS, fluticasone propionate, and/or salmeterol or a combination of these factors. In extensive US and worldwide postmarketing experience with salmeterol, a component of ADVAIR DISKUS, 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. 2), 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. | ||||
Email this article
Printer friendly
Bookmark this pageadvertisement
