Advair Diskus

[Salmeterol/Fluticasone]

Cardiovascular: Arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), ventricular tachycardia.

Ear, Nose, and Throat

Aphonia, earache, facial and oropharyngeal edema, paranasal sinus pain, throat soreness.

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Endocrine and Metabolic

Cushing syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism, hyperglycemia, weight gain, osteoporosis.

Eye

Cataracts, glaucoma.

Gastrointestinal

Abdominal pain, dyspepsia, xerostomia.

Musculoskeletal

Back pain, cramps, muscle spasm, myositis.

Neurology

Paresthesia, restlessness.

Non-Site Specific

Immediate and delayed hypersensitivity reaction (including very rare anaphylactic reaction), pallor. Very rare anaphylactic reaction in patients with severe milk protein allergy.

Psychiatry

Agitation, aggression, depression.

Respiratory

Chest congestion; chest tightness; dyspnea; immediate bronchospasm; influenza; paradoxical bronchospasm; tracheitis; wheezing; reports of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking.

Skin

Contact dermatitis, contusions, ecchymoses, photodermatitis.

Urogenital

Dysmenorrhea, irregular menstrual cycle, pelvic inflammatory disease, vaginal candidiasis, vaginitis, vulvovaginitis.

Eosinophilic Conditions

In rare cases, patients on inhaled fluticasone propionate, a component of ADVAIR DISKUS, may present with systemic eosinophilic conditions, with some patients presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported with other inhaled corticosteroids in this clinical setting.

While ADVAIR DISKUS should not be used for transferring patients from systemic corticosteroid therapy, physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between fluticasone propionate and these underlying conditions has not been established (see PRECAUTIONS: General: Eosinophilic Conditions).

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